Lot #8016512

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA. || The product is used for long term hemodialysis vascular access.

Lot #RL7075136, RL7034391, RL6083099, RL6083037, RL6062789, RL6011934, RL5121649, RL5111321, RR5101165, RF5084348, and RF5072121

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CS-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

: Lot #RL7075139, RL7065023, RL7054780, RL7034392, RL7024053, RL7013830, RL6123783, RL610333, RL6083093, RL6072881, RL6062814, RL6062784, RR5101166, RL5090831, and RL5090775.

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CS-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL7075137, RL7065025, RL7054779, RL7034394, RL6113594, RL6083058, RL5121614, RR5101169, RL5090832, RL5090780, and RF5054551

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CS-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL7013940, RL6062791, RR5101168, RL5090833, and RL5090776

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA. || The product is used for long term hemodialysis vascular access.

Lot# RL7034397, RL7013939, RL6062815, RL6062792, RL5121654, RL5090834, RL5080628, and RF5060906

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL7065082, RL6093295, and RL6082990

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL7075214, RL6103402, and RL6083025

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CSD-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL6123742, RL6083061, and RL6082992

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CSD-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Lot# RL7064991,and RL6083027

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA. || The product is used for long term hemodialysis vascular access.

Lot# RL7065084, and RL6093204

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA. || The product is used for long term hemodialysis vascular access.

Product manufactured from January 2006 through July 2008; Product Description: HEMOCLIP MEDIUM 250/BOX, Product Code: 523100, Lot number: 01C0800066, 01D0800156, 01D0800324, 01E0800203, 01E0800410, 01K0700113, 01K0700198, 01K0700298, 01L0700009, 01M0700131, T1202225, T1202961, T1209529, T1211719, T1213975, T1220115, T1226528, T1228532, T1229942, T1233481, T1235583, T1236588, T1239523, T1242799, T1248517, T1249582, T1250496, T1252394, T1255378, T1256389, T1258311, T1261008, T1262892, T1264925, T1270366, T1272027, T1273754, T1275784, T1277275, and T1280263; Product Description: HEMOCLIPS SMALL 300/BOX, Product Code: 523135, Lot number: 01A0800221, 01B0800284, 01E0800020, 01E0800051, 01E0800205, 01K0700299, 01L0700097, 01M0700054, T1202223, T1207485, T1210251, T1218339, T1224895, T1229939, T1231420, T1235581, T1239179, T1241604, T1243428, T1247446, T1248346, T1256385, T1258309, T1260080, T1261781, T1270990, T1272023, and T1276617; Product Description: HEMOCLIP MED-LGE 200/BOX, Product Code: 523160, Lot number: 01K0700199, 01L0700098, T1201401, T1202195, T1210839, T1213979, T1229935, T1237417, T1240028, T1242797, T1260076, and T1271937; Product Description: HEMOCLIP LARGE 150/BOX, Product Code: 523170, Lot number: 01A0800325, 01D0800157, 01E0800018, 01L0700340, T1198153, T1201448, T1203611, T1210220, T1214463, T1218859, T1228527, T1237522, T1238441, T1242798, T1246173, T1248344, T1253536, T1254318, T1255373, T1258761, T1262886, T1264105, T1276611, and T1280177; Product Description: HEMOCLIP TEN PAK MEDIUM 200/BOX, Product Code: 523300, Lot number: 01B0800289, 01D0800158, 01F0800071, 01K0700200, 01K0700300, 01L0700010, 01M0700055, T1195698, T1203615, T1208575, T1213976, T1216526, T1227714, T1228534, T1231501, T1233521, T1234311, T1252395, T1254402, T1260323, T1262893, T1266943, T1270995 and T1276883; Product Description: HEMOCLIP TEN PAK SMALL 240/BOX, Product Code: 523335, Lot number: 01A0800327, 01C0800296, 01D0800159, T1203612, T1213977, T1221073, T1225877, T1230388, T1237120, T1239180, T1241605, T1251449, T1253540, T1260321, T1261792, T1273752, and T1277291; Product Description: HEMOCLIP TEN PAK MED-LG 160/BX, Product Code: 523360, Lot number: 01A0800328, 01C0800244, T1195769, T1196987, T1199780, T1208571, T1218337, T1229936, T1237418, T1247368, T1255369, T1264918, T1271938, and T1273748; Product Description: HEMOCLIP TEN PAK LG 120/BOX, Product Code: 523370, Lot number: 01C0800245, T1202199, T1209526, T1211715, T1227696, T1234309, T1238442, T1239176, T1243426, T1245243, T1248508, T1250484, T1254319, T1267799, T1268809, T1275639, T1276612, T1278104, and T1279053; Product Description: HEMOCLIP S/S MEDIUM 250/BOX, Product Code: 523400, Lot number: 01A0800329, 01D0800086, 01E0800409, T1226527, T1226762, T1229941, T1232352, T1237527, T1238445, T1248515, T1249520, T1250494, T1251452, T1261740, T1262890, T1264923, T1266142, T1270993, T1272025, T1275783, T1278107, and T1279058; Product Description: HEMOCLIP S/S SMALL 300/BOX, Product Code; 523435, Lot number: 01E0800144, 01L0700182, 01M0700132, T1200641, T1232348, T1239177, T1247445, T1255376, T1257214, T1262887, and T1276616; Product Description: HEMOCLIP S/S MED/LG 200/BOX, Product Code: 523460, Lot number: 01B0800076, 01D0800234, 01L0700258, T1201481, T1203609, T1206790, T1212659, T1219274, T1224891, T1234306, T1239175, T1245241, T1252391, T1255370, T1271939, and T1277285; Product Description: HEMOCLIP S/S LARGE 150/BOX, Product Code: 523470, Lot number: 01B0800163, 01C0800064, 01L0700171, 01M0700133, T1214678, T1226761, T1229937, T1237523, T1240293, T1255374, T1257213, T1260078, T1267800, T1276613, T1277287, and T1280178; Product Description: HEMOCLIP S/S MEDIUM 200/BOX, Product Code: 523600, Lot number: 01B0800389, 01D0800160, 01E0800021, 01L0700099, 01M0700134, T1211718, T1216521, T1227711, T1230389, T1238446, T1242668, T1247371, T1251453, T1256388, T1262891, T1264924, T1266942, T1270994, T1272879, T1277274, and T1280262; Product Description: HEMOCLIP S/S SMALL 240/BOX, Product Code: 523635, Lot number: 01A0800050, 01A0800169, 01C0800143, 01C0800246, 01C0800295, 01D0800236, T1201422, T1202222, T1206018, T1209527, T1211716, T1213978, T1221290, T1224894, T1227708, T1230387, T1233478, T1237119, T1239178, T1240295, T1253538, T1259106, T1262888, T1266119, T1268812, T1270989, T1273751, T1278105, and T1279054; Product Description: HEMOCLIP S/S MEDIUM-LARGE 160/BOX, Product Code: 523660, Lot number: 01A0800037, T1202196, T1256382, T1262885, and T1271940; Product Description: HEMOCLIP S/S LARGE 120/BOX, Product Code: 523670, Lot number: 01A0800051, 01C0800065, T1228528, T1237524, T1245245, T1248345, T1266118, and T1277288; Product Description: HEMOCLIP TITANIUM MEDIUM 250/BOX, Product Code: 523700, Lot number: 01A0800052, 01A0800170, 01A0800331, 01A0800426, 01A0800427, 01B0800390, 01D0800087, 01D0800088, 01D0800283, 01D0800325, 01E0800412, 01K0700286, 01L0700100, 01L0700342, T1202226, T1203616, T1214464, T1222328, T1223063, T1224897, T1226763, T1230390, T1231505, T1232353, T1233482, T1234312, T1235584, T1236584, T1238447, T1244668, T1248519, T1249585, T1252396, T1253543, T1255379, T1255380, T1257215, T1258314, T1259111, T1260324, T1261794, T1262894, T1264108, T1266144, T1266944, T1268384, T1270368, T1270996, T1272028, T1272029, T1273755, T1275785, and T1279059; Product Description: HEMOCLIP TITANIUM SMALL 300/BOX, Product Code: 523735, Lot number: 01B0800315, 01C0800145, 01C0800297, 01D0800395, 01E0800146, 01E0800204, T1192807, T1195697, T1202224, T1216520, T1221291, T1222327, T1223064, T1226526, T1228531, T1229940, T1232349, T1236587, T1237526, T1239521, T1241480, T1243837, T1245247, T1249518, T1251450, T1252393, T1253541, T1258215, T1259108, T1261004, T1262889, T1266941, T1268815, T1270364, T1270991, T1272877, T1273753, T1275781, T1276620, T1278106, and T1279056; Product Description: HEMOCLIP TITANIUM MEDIUM-LARGE 200/BOX, Product Code: 523760, Lot number: 01A0800222, 01B0800077, 01D0800008, 01D0800164, 01E0800143, T1202197, T1208572, T1210838, T1234307, T1237419, T1247369, T1252392, T1256383, T1257719, T1258560, T1259103, T1261790, T1266799, T1272021, T1273749, and T1277286; Product Description: HEMOCLIP TITANIUM LARGE 150/BOX, Product Code: 523770, Lot number: 01A0800054, 01D0800235, 01D0800322, 01L0700011, 01L0700260, T1202200, T1215225, T1220112, T1224663, T1227699, T1228529, T1237525, T1238443, T1244223, T1247370 , T1248510 , T1250486 , T1254320, T1259104, T1264919, T1272875, T1276614, and T1280179; Product Description: HEMOCLIP TITANIUM MEDIUM 200/BOX, Product Code: 523800, Lot number 1A0800223, 01A0800428, 01B0800165, 01C0800247, 01C0800299, 01D0800089, 01D0800288, 01D0800337, 01E0800023, 01K0700301, 01L0700012, 01L0700178, 01L0700261, 01L0700343, 01M0700136, T1192808, T1202227, T1206021, T1207491, T1213973, T1222336, T1223062, T1224085, T1226764, T1228535, T1229944, T1231510, T1232354, T1233483, T1234314, T1235585, T1238448, T1239525, T1241011, T1241602, T1242669, T1243437, T1244224, T1244667, T1247447, T1248348, T1249587, T1250498, T1252397, T1252398, T1253544, T1254404, T1256391, T1258216, T1259112, T1260326, T1260617, T1261795, T1261796 T1264109, T1264926, T1266145, T1266946, T1268385, T1270369, T1270997, T1272880, T1273756, T1275787, T1276885, T1278109, and T1279060; Product Description: HEMOCLIP TITANIUM SMALL 240/BOX, Product Code: 523835, Lot number: 01A0800171, 01A0800224, 01C0800146, 01C0800248, 01C0800298, 01D0800146, 01D0800161, 01D0800323, 01E0800290, 01F0800084, 01K0700114, 01K0700202, 01K0700302, 01L0700161, 01L0700262, 01L0700344, 01M0700137, T1195699, T1208574, T1213974, T1217528, T1224083, T1227710, T1232350, T1233479, T1235582, T1241601, T1246175, T1248347, T1249519, T1251451, T1256386, T1258310, T1260322, T1261006, T1264107, T1264922, T1266141, T1268381, T1268816, T1270365, T1270992, T1272878, T1275782, T1276881, and T1277293; Product Description: HEMOCLIP TITANIUM MEDIUM-LARGE 160/BOX, Product Code: 523860, Lot number: 01K0700203, 01L0700013, 01L0700183, 01M0700138, T1195700, T1201399, T1202198, T1202860, T1203610, T1206016, T1213980, T1218338, T1226600, T1227690, T1230384, T1234308, T1235439, T1237521, T1238396, T1240292, T1244666, T1245242, T1248343, T1253535 , T1255372, T1256384, T1260077, T1261791, T1262882, T1264104, T1266117, T1266800, T1272022, T1273750, T1278103, and T1279050; Product Description: HEMOCLIP TITANIUM LARGE 120/BOX, Product Code: 523870, Lot number: 01A0800055, 01B0800388, 01C0800294, 01D0800165, 01E0800019, 01E0800206, 01K0700303, 01L0700014, 01L0700184, T1192809, T1202221, T1212660, T1220113, T1225876, T1227701, T1230386, T1236585, T1238444, T1244676, T1246174, T1248512, T1253537, T1254401, T1255375, T1258762, T1260079, T1261782, T1264920, T1268810, T1272876, T1276615, and T1280180.

General and Plastic Surgery Devices

2

Yes

Nationwide

Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

Product manufactured from January 2006 through July 2008;  Product Description; HEMO PLUS TITANIUM MEDIUM 25CLIP/10CART, Product Code: 533700, Lot number: 01B0800080, 01C0800069, 01E0800024, 01K0700109, 01K0700306, 01L0700104, 01M0700058, T1195792, T1202229, T1202963, T1206022, T1206785, T1210254, T1214002, T1224089, T1228537, T1232357, T1234317, T1240300, T1247376, and T1254408; Product Description: HEMO PLUS TI 25/CART 250BOX NO TAPE, Product Code: 533702, Lot number: 01B0800290, 01E0800025, 01E0800293, 01M0700139, T1199967, T1203683, T1221295, T1225871, T1232358, T1234318, T1251457, T1257218, T1258316, T1259116, T1268818, T1270999, T1278115, and T1279064; Product Description: HEMO PLUS TITANIUM SMALL 25CLIP/12CART, Product Code: 533735, Lot number: 01A0800010, 01C0800109, T1201389, T1206042, T1206786, T1207492, T1208578, T1214465, T1224086, T1228536, T1231515, T1234316, T1238449, T1239526, T1246179, T1250500 T1254405, T1262895, and T1272030; Product Description: HEMO PLUS TI 25/CART 300BOX NO TAPE, Product Code: 533737, Lot number: 01E0800055, 01E0800056, 01M0700059, T1192804, T1194951, T1196289, T1202185, T1203619, T1210837, T1214003, T1215227, T1217531, T1221292, T1225870, T1229945, T1232356, T1233484, T1235586, T1240297, T1247375, T1251454, T1257216, T1260327, T1266947, T1268387, and T1278110; Product Description: HEMO PLUS TITANIUM MEDIUM 10 CLIP/18CART, Product Code: 533800, Lot number: 01A0800013, 01A0800185, 01A0800186, 01A0800229, 01A0800230, 01A0800314, 01A0800336, 01A0800392, 01A0800433, 01D0800084, 01D0800328, 01E0800149, 01F0800074, 01K0700003, 01K0700116, 01K0700204, 01L0700018, 01L0700188, 01L0700265, 01M0700060, T1201390, T1203684, T1208580, T1212802, T1217533, T1218343, T1221294, T1222331, T1222960, T1224090, T1224964, T1226766, T1232359, T1233485, T1234319, T1235590, T1236583, T1240321, T1242824, T1243562, T1244226, T1245248, T1246361, T1247377, T1252441, T1252442, T1254409, T1256392, T1257219, T1258317, T1259117, T1260329, T1261011, T1262820, T1264112, T1264113, T1264928, T1266149, T1268391, T1268819, T1275790, T1276887, T1277326, T1278116, and T1280265; Product Description: HEMO PLUS TI M10/18CART NO TAPE, Product Code: 533802, Lot number: 01A0800187, 01A0800337, 01B0800081, 01B0800291, 01D0800009, 01K0700004, T1195762, T1198822, T1205309, T1209534, T1225872, T1229947, T1237528, T1239527, T1242825, T1246362, T1255383, T1257220, T1259118, T1260330, T1264114, T1268392, T1268820, T1271000, T1273222, T1275791, T1278117, and T1279066; Product Description: HEMO PLUS TITANIUM SMALL 10 CLIP/18 CART, Product Code: 533835, Lot number: 01A0800011, 01A0800059, 01D0800081, 01D0800082, 01D0800326, 01E0800148, 01K0700205, 01K0700307, 01L0700105, 01L0700349, 01M0700140, T1195763, T1202228, T1203681, T1205302, T1208579, T1218922, T1222329, T1222959, T1224962, T1236590, T1238450, T1241603, T1244677, T1246180, T1249588, T1250501, T1251455, T1254407, T1259115, T1261009, T1262896, T1264110, T1266147, T1266948, T1268388, T1268817, T1275788, T1276886, and T1277323; Product Description: HEMO PLUS TI S10/18CART NO TAPE, Product Code: 533837, Lot number: 01A0800060, 01A0800338, 01D0800083, 01D0800327, 01K0700117, 01L0700106, T1192805, T1196288, T1202962, T1209531, T1224087, T1227715, T1230391, T1235587, T1242821, T1243440, T1244225, T1247503, T1251456, T1261797, T1264111, T1270370, T1273757, and T1280264; Product Description: HEMO PLUS TITANIUM MED-LGE 10CLIP/12CART, Product Code: 533860, Lot number: 01A0800101, 01A0800174, 01A0800339, 01B0800169, 01D0800085, 01E0800199, 01F0800075, 01K0700308, 01L0700019, 01L0700266, 01M0700061, T1201391, T1208601, T1215228, T1219118, T1220119, T1222330, T1223061, T1224966, T1225873, T1233486, T1234320, T1236337, T1245249, T1249589, T1251458, T1252443, T1264929, T1266949, T1269021, T1276888, and T1277328; Product Description: HEMO PLUS TI ML10/12CART NO TAPE, Product Code: 533862, Lot number: 01A0800340, T1195764, T1205306, T1225874, T1227718, T1231520, T1233487, T1242826, T1246363, T1248465, T1250503, T1251459, T1257301, T1261012, T1266950, T1271001, and T1280266; Product Description: HEMO PLUS TITANIUM LARGE 10CLIP/12CART, Product Code: 533870, Lot number: 01A0800231, 01D0800295, 01F0800014, 01F0800076, 01L0700020, 01L0700189, 01M0700141, T1199779, T1203685, T1206784, T1210835, T1211782, T1216524, and T1221072; Product Description: HEMO PLUS TI L10/12CART NO TAPE, Product Code: 533872, Lot number: 01B0800393, 01F0800077, 01L0700267, T1199778, T1220120, T1234381, T1244678, T1252444, T1254410, and T1270372; Product Description: HEMO PLUS STRGPT TI SM25/CART, Product Code: 534735, 300/BX, Lot number: 01C0800067, T1196287, T1199966, T1205303, T1218342, T1220117, T1230392, T1238451, T1242822, T1273221, T1278111, and T1279061; Product Description: HEMO PLUS STRONGPOINT SM NOTAPE 300 25, Product Code: 534737, Lot number: 01D0800162, T1201388, T1209532, T1210253, T1217532, T1224088, T1227717, T1235588, T1240298, T1260328, T1268389, T1278112, and T1279062; Product Description: HEMO PLUS STRGPT TI SM10/CART 180BX, Product Code: 534835, Lot number: 01A0800012, 01A0800434, 01B0800392, 01E0800292, 01E0800415, 01K0700206, 01M0700062, T1195765, T1203682, T1205304, T1209533, T1221293, T1225308, T1226765, T1229946, T1231519, T1238452, T1240299, T1242823, T1250502, T1252400, T1257217, T1258315, T1264927, T1268390, T1275789, T1277325, and T1278113; Product Description: HEMO PLUS STRONGPOINT SM NO TAPE 180 10, Product Code: 534837, Lot number: T1220118, T1235589, T1261010, T1266148, T1278114, and T1279063.

General and Plastic Surgery Devices

2

Yes

Nationwide

Weck Hemoclip Plus¿ Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

Product manufactured from January 2006 through July 2008; Product Description: HORIZON SMALL TI 6 CLIP, Product Code, 001200, Lot Number: 01A0800045, 01A0800319, 01A0800417, 01B0800210, 01B0800307, 01B0800318, 01B0800381, 01C0800054, 01C0800235, 01C0800308, 01D0800032, 01D0800149, 01D0800263, 01E0800030, 01E0800138, 01E0800139, 01K0700193, 01K0700292, 01L0700001, 01L0700089, 01L0700179, 01L0700250, 01L0700332, 01M0700045, 01M0700124, T1196255, T1201496, T1202233, T1202969, T1211681, T1212807, T1214012, T1214145, T1214803, T1215232, T1216179, T1217538, T1219268, T1219949, T1221287, T1222337, T1222951, T1223070, T1223894, T1224976, T1225863, T1226772, T1227726, T1229961, T1233420, T1234210, T1240153, T1240325, T1242673, T1243571, T1244228, T1244723, T1245254, T1246551, T1250514, T1251540, T1252517, T1253551, T1254473, T1266156, T1266961, T1269027, T1272020, T1275128, T1275797, T1277337, T1278125, and T1279073. Product Description: HORIZON SMALL RED TI 6 CLIP WIDE SLOT, Product Code: 001201, Lot Number: 01A0800043, 01A0800165, 01A0800217, 01A0800311, 01A0800418, 01A0890013, 01B0800068, 01B0800151, 01B0800159, 01B0800247, 01C0800055, 01C0800151, 01C0800236, 01C0800309, 01D0800106, 01D0800150, 01D0800264, 01E0800031, 01K0700110, 01K0700194, 01K0700195, 01K0700293, 01L0700002, 01L0700090, 01L0700180, 01L0700251, 01L0700333, 01M0700046, 01M0700125, T1202970, T1203693, T1209125, T1209540, T1210249, T1211682, T1212302, T1212808, T1214013, T1214804, T1215233, T1216180, T1217539, T1218205, T1219269, T1219948, T1221078, T1221286, T1222338, T1222339, T1223892, T1224977, T1225864, T1226773, T1227727, T1228570, T1228610, T1229962, T1230586, T1231598, T1232375, T1233421, T1234211, T1234998, T1236595, T1238043, T1238498, T1239532, T1244229, T1244724, T1245255, T1246344, T1247434, T1248472, T1250515, T1251359, T1252518, T1253552, T1254474, T1255175, T1255389, T1256398, T1256399, T1257313, T1257314, T1258302, T1258344, T1259129, T1259130, T1260339, T1260340, T1261021, T1261809, T1263003, T1264939, T1266157, T1266158, T1266959, T1266960, T1268397, T1268398, T1268855, T1269028, T1269784, T1272061, T1272062, T1273232 T1273235, T1275142, T1275146, T1275798, T1276895, T1277338, T1278126, T1278127, T1279074, and T1279915. Product Description: HORIZON MED TI CLIP, Product Code: 002200, Lot number: 01A0800047, 01A0800093, 01A0800167, 01A0800215, 01A0800276, 01A0800277, 01A0800313, 01A0800421, 01B0800071, 01B0800161, 01B0800296, 01B0800382, 01C0800056, 01C0800139, 01C0800239, 01C0800310, 01D0800023, 01D0800112, 01D0800233, 01E0800080, 01E0800140, 01E0800302, 01F0800081, 01F0800379, 01L0700004, 01L0700173, 01L0700181, 01L0700252, 01L0700334, 01M0700222, T1205292, T1206699, T1207473, T1208607, T1209126, T1209541, T1210250, T1211683, T1212809, T1213972, T1214009, T1214809, T1215180, T1216202, T1217540, T1219270, T1219944, T1220367, T1221276, T1222225, T1222801, T1223071, T1223895, T1224978, T1225865, T1226774, T1227728, T1228611, T1229615, T1230587, T1230588, T1231599, T1232376, T1233422, T1234212, T1234999, T1236596, T1238499, T1239533, T1241009, T1241609, T1243104, T1243105, T1243572, T1244230, T1244511, T1244725, T1246548, T1247435, T1248473, T1249599, T1250516, T1251541, T1252519, T1253553, T1256400, T1256401, T1257315, T1258345, T1259832, T1260421, T1261022, T1261810, T1264227, T1264826, T1264940, T1266341, T1266343, T1268399, T1269029, T1269030, T1270230, T1270231, T1271007, T1271008, T1272063, T1272064, T1273237, T1275155, T1275799, T1277428, T1277429, T1278128, T1279075, and T1279916. Product Description: HORIZON MED/LRG TI 6 CLIP, Produce Code: 003200, Lot number: 01A0800048, 01A0800194, 01A0800346, 01A0890012, 01B0800073, 01B0800162, 01B0800248, 01B0800297, 01B0800383, 01C0800057, 01C0800241, 01C0800311, 01D0800033, 01D0800154, 01D0800280, 01D0800335, 01D0800369, 01E0800141, 01E0800422, 01F0800036, 01F0800082, 01F0800169, 01K0700296, 01L0700006, 01L0700094, 01L0700174, 01L0700254, 01L0700330, 01L0700335, 01M0700049, 01M0700122, 01M0700123, T1196254, T1201499, T1202234, T1202235, T1202971, T1203694, T1206023, T1206700, T1207474, T1208563, T1209378, T1214014, T1214468, T1216782, T1218206, T1219271, T1219945, T1220365, T1221272, T1222958, T1223896, T1224979, T1226775, T1228342, T1229963, T1230589, T1231600, T1232377, T1233424, T1234213, T1235000, T1236554, T1236935, T1238503, T1239534, T1240141, T1241017, T1243128, T1244670, T1245256, T1246549, T1247342, T1247436, T1251542, T1252520, T1253554, T1254475, T1256402, T1257316, T1258346, T1259131, T1260422, T1261023, T1261811, T1263004, T1264228, T1264941, T1266344, T1266962, T1268400, T1269031, T1270232, T1271009, T1271010, T1272065, T1272066, T1273239, T1275168, T1275800, T1276896, T1277339, T1278129, T1279076, and T1279917. Product Description: HORIZON LARGE TI 6 CLIP, Product Code: 004200, Lot number: 01A0800014, 01A0800136, 01A0800220, 01A0800322, 01A0800424, 01B0800074, 01B0800384, 01C0800058, 01C0800242, 01D0800034, 01D0800155, 01E0800192, 01E0800304, 01E0800423, 01K0700009, 01K0700112, 01K0700297, 01L0700095, 01L0700175, 01L0700255, 01L0700337, 01M0700190, T1196253, T1206015, T1206781, T1207475, T1208564, T1209377, T1210120, T1210813, T1212330, T1214015, T1217541, T1219273, T1221273, T1223072, T1223897, T1225866, T1227729, T1228612, T1230590, T1231601, T1232378, T1233428, T1234214, T1235421, T1236194, T1237537, T1238505, T1239535, T1243129, T1245257, T1246550, T1247397, T1248462, T1249600, T1251220, T1252521, T1253555, T1254476, T1255390, T1256403, T1257318, T1257328, T1258347, T1259132, T1260423, T1261024, T1261812, T1262821, T1264229, T1264942, T1266346, T1266963, T1273809, T1275119, T1275430, T1275841, T1276897, T1277340, T1279077, and T1279918. Product Description: HORIZON MICRO TI 6 CLIP/CART 30 CART/BX, Product Code; 005200, Lot number: 01A0800044, 01B0800305, 01B0800385, 01D0800035, 01E0800193, 01E0800214, 01F0800083, 01L0700256, 01L0700338, 01M0700051, T1199816, T1203695, T1208608, T1212811, T1214016, T1219272, T1221288, T1227730, T1228613, T1238191, T1244726, T1247398, T1251543, T1253556, T1257319, T1262053, T1263005, T1275842, and T1278131.

General and Plastic Surgery Devices

2

Yes

Nationwide

Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

Product manufactured from January 2006 through July 2008; (Product Description: HOL SMALL CLIPS 1 PACK, Product Code: 544210, Lot number: 01C0800150, and T1278089; Product Description: HOL SMALL CLIPS 4 PACK, Product Code: 544214, Lot number: T1278090, and T1278091; Product Description: HOL SMX CLIPS, Product Code: 544220, Lot number: 01D0800096, 01D0800274, 01M0700186, T1199965, T1203687, T1217534, T1228540, T1238491, T1240322, T1250508, T1254468, T1260331, T1261800, T1264120, T1264930, T1266953, T1271002, T1275103, and T1279909; Product Description: HOL ML CLIPS, Product Code: 544230, Lot number: 01A0800008, 01A0800061, 01A0800062, 01A0800177, 01A0800233, 01A0800344, 01A0800435, 01B0800174, 01B0800293, 01B0800374, 01C0800060, 01C0800149, 01C0800302, 01D0800094, 01D0800136, 01D0800275, 01E0800079, 01E0800112, 01E0800159, 01E0800249, 01E0800334, 01F0800022, 01F0800117, 01K0700006, 01K0700119, 01M0700014, 01M0700147, T1202230, T1202965, T1203688, T1213241, T1214808, T1218508, T1220366, T1222324, T1225867, T1226767, T1228410, T1228561, T1229915, T1230518, T1231590, T1232367, T1233411 , T1234215, T1235422, T1237016, T1238490, T1239528, T1244679, T1246346, T1246459, T1247429, T1249597, T1252218, T1252509, T1253546, T1254469, T1256202, T1256393, T1257303, T1258318, T1259122, T1261014, T1261801, T1262898, T1264221, T1264931, T1266150, T1266151, T1266954, T1268393, T1272013, T1272014, T1273718, T1276889, T1276890, T1277330, T1278118, T1279067, and T1279910; Product Description: HOL L CLIPS, Product Code: 544240, Lot number: 01A0800007, 01A0800094, 01A0800139, 01A0800188, 01A0800234, 01A0800318, 01A0800382, 01A0800383, 01B0800040, 01B0800047, 01B0800048, 01B0800116, 01B0800130, 01B0800205, 01B0800206, 01B0800331, 01C0800007, 01C0800008, 01C0800076, 01C0800107, 01C0800184, 01C0800254, 01D0800001, 01D0800002, 01D0800111, 01D0800198, 01D0800199, 01D0800277, 01D0800329, 01E0800009, 01E0800057, 01E0800058, 01E0800160, 01E0800161, 01E0800250, 01E0800251, 01E0800296, 01E0800353, 01E0800416, 01E0800417, 01F0800037, 01K0700008, 01K0700120, 01K0700272, 01L0700021, 01L0700107, 01L0700190, 01L0700271, 01M0700098, 01M0700126, and 01M0700148; Product Description: HOL XL CLIPS (EXTRA LARGE), Product Code: 544250, Lot number: 01A0800436, 01B0800082, 01B0800175, 01B0800294, 01B0800375, 01C0800255, 01C0800304, 01D0800141, 01E0800252, 01E0800352, 01K0700209, 01K0700310, 01L0700022, 01L0700191, 01L0700268, T1195768, T1202966, T1203690, T1208603, T1210246, T1211617, T1216058, T1221102, T1223849, T1226768, T1227722, T1228562, T1229917, T1230520, T1231592, T1232369, T1233413, T1234217, T1235424, T1236592, T1237531, T1238493, T1240323, T1244680, T1246541, T1247431, T1249598, T1250510, T1251534, T1252511, T1253547, T1256395, T1257305, T1258320, T1259124, T1261803, T1262822, T1262900, T1266956, T1268394, T1269024, T1270229, T1271005, T1273225, T1273797, T1275793, T1276892, T1277331, T1278121, and T1279068

General and Plastic Surgery Devices

2

Yes

Nationwide

WECK Hem-o-lok¿¿ Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

Product Code: 527100, Product Description: HemoClip Auto S/S Medium 200/Box; Product Code: 527200, Product Description: HemoClip Auto Titanium Medium 200/Box and Product Code: 527203, Product Description: HemoClip Auto Titanium Medium 100/Box.

General and Plastic Surgery Devices

2

Yes

Nationwide

WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

All lots of Product codes listed in Z-1489-2009.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.

Arrow Peripherally Inserted Central Catheter

Catalog Number: EP4084N, Lot number: 02A0801449

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution: USA and Germany

Deknatel Bondek¿ Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Catalog Number: EP1081P, Lot number: 02A0801448, 02A0802800, 020A802802 and 02A0801433.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution: USA and Germany

Deknatel Bondek¿ Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical.

Product number ASK-01451-BMH - Lot numbers RF8060214 and RF8096394; Product number ASK-05041-CHC - Lot numbers RF8109279 and RF9056727; Product number ASK-05041-CHC1 - Lot numbers RF9069677 and RF9098408; Product number ASK-05041-CHM - Lot numbers RF8057827 and RF8068899; Product number ASK-05041-HMC - Lot numbers RF8068662, RF8083994, RF8108545, RF9043625, RF9056403, RF9085278, and RF9098580; Product number ASK-05041-QV - Lot number RF9097395; Product number ASK-07041-BMH - Lot numbers RF9031839, RF9098784, and RL8108648; Product number CN-05041-LW - Lot numbers RF8069608, RF9056127, RF9070920, and RL9019402; Product number MSO-01451-UCL - Lot numbers RF9057410, RF9084460, RL8118758, and RL9029477; Product number MTO-01451-RH - Lot number RL9019228; Product number PL-05041 - Lot numbers RF8071766 and RF9109677; Product number PR-04041-HPX - Lot numbers RF8072920 and RF8109646; Product number PR-05041 - Lot numbers RF8056742, RF8068423, RF8069651, RF8071677, RF8095208, RF8095832, RF8108465, RF9028902, RF9043449, RF9056132, RF9085152, and RF9086357; Product number PR-05041-HP - Lot numbers RF8072840, RF8083506, RF8084926, and RF8107907; Product number PR-05041-HPX - Lot numbers RF8071099, RF8072981, RF9015967, RF9057607, and RF9097057; Product number PR-05041-LW - Lot numbers RF8057252, RF8072743, RF8083529, RF8108466, RF8110585, RF9031472, RF9044054, RF9060502, and RF9097058; Product number PR-05041-MW - Lot numbers 8057253, RF8060216, RF8095834, RF8108467, RF8110586, RF9016412, RF9031473, RF9044055, RF9069045, RF9071244, RF9085152, RF9086354, RF9100412, and RF9109679; Product number PR-05041-T - Lot numbers RF8068845 and RF8107962; Product number PR-05042 - Lot numbers RF8068846, RF8107963, RF8122680, RF9016413, RF9044057, and RF9073297; Product number PR-05541-HPX - Lot number RF8124014; Product number PR-07041-PTSP - Lot numbers RF8068850, RF8071679, RF8107965, RF8110358, RF9042708, and RF9072922; and Product number RJ-01451-W - Lot numbers RF8068664, RF8096774, RF8123596, and RF9060298.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.

Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP EU-25041-HPMSB EU-25041-IR EU-25541-HP EU-25541-HPMSB EU-25541-IR FR-04041 FR-04041-CF FR-05041 FR-05041-CF PR-04041-HPX PR-05041-HP PR-05541-HPX UK-04041-RDE1 UK-04041-THT UK-05041-HPMIN UK-05041-MSB UK-05041-RDE1 UK-05041-THT with Batch Nos. 23F15E0620 23F15A0584 23F14H0964 23F14F1422 23F13J0289 23F13H0832 23F15C2435 23F14L0090 23F14H0848 23F14F0370 23F14A1352 23F13K0761 23F14H0193 23F15C1236 23F14M0484 23F14L0810 23F14K1361 23F14J0415 23F14E1093 23F14B0844 23F15D0881 23F14L0187 23F15F0752 23F15A1857 23F15D0830 23F14H1112 23F14F1497 23F14C1096 23F14C0640 23F14A1238 23F14A1419 23F14L1144 23F14J1513 23F15D0832 23F15F0147 23F15C0303 23F14J0221 23F14F1504 23F14C0643 23F13K0097 23F13H0994 23F13H0013 23F15F0151 23F15C1553 23F15B0400 23F14K1025 23F14H0328 23F14F1505 23F14C0598 23F13K0003 71F14L0736 71F14K1846 71F15B1940 71F13M1092 71F13L0510 71F14A1536 71F14C0247 71F14B1735 71F14F1289 71F14E2029 71F14J1087 71F14K0628 71F14K0081 71F14L0762 71F14L0323 71F14M0678 71F15A0395 71F15B0648 71F15C0214 71F15D0234 71F15D0053 71F15D1075 23F14G1130 23F14F0115 23F14C0576 23F14A1241 23F13K1064 23F13H0034 23F15D1021 23F14D0713 23F14C0575 23F14A1240 23F13K1065 23F13J1118 23F13H0692 71F13G0655 71F13H1053 71F13H0599 71F13H0225 71F13J0124 71F13J1293 71F13K1289 71F13M0785 71F14A1326 71F14B0312 71F14B0879 71F14E1533 71F14E1967 71F14F1290 71F14G0365 71F14F1358 71F14H0351 71F14H0947 71F14J0869 71F14H1396 71F14K0622 71F14K0082 71F14K1332 71F14M0141 71F15A0152 71F15A1289 71F15A1984 71F15B0638 71F15C1137 71F15D0272 71F15D1059 23F14D1125 23F14D0217 23F14B1013 71F15D1630 71F15F1435 71F14J1734 71F14H1167 71F14M0143 71F15B0996 71F15B0224 71F15C0128 71F15D0578 71F15C1592 71F15D1983 71F15E1582 71F15F1737 71F15E1216 71F15D1909 71F14J1735 71F14H1165 71F15A0163 71F15B0228 71F15C0812 71F15C0215 71F15D0682 71F15D0222 71F15D1717 71F15F1736 71F15E1217 71F15F1863 71F15E1185 71F15F1436 71F15F1310 71F15F2106 71F14H0441 71F14L0582 71F14M0144 71F14M0820 71F15A0123 71F15B1011 71F15A1661 71F15C1593 71F15E0165 71F15F1731 71F15E1220 71F14K1569 71F15D0052 71F13L0991 71F13M1110 71F13M0627 71F14A0698 71F14C0579 71F14D0710 71F14F1217 71F14H0374 71F14J1086 71F14K1198 71F14L1345 71F15A1660 71F15B1938 71F15D1077 71F15D0235 71R15E0455 71F15F1185 71F14K1571 71F13G0162 71F13K1107 71F14A1940 71F14A0150 71F14E2043 71F14F1786 71F14F1844 71F14G1690 71F14K0639 71F14L0577 71F14L1347 71F15A1302 71F15B0662 71F15B1937 71F15D0681 71F15E1403 71F14B1741 71F14E0087 71F14E2044 71F14F1785 71F14J1860 71F15A0300 71F15C2011 71F15E1405 23F14E0187 23F15F0261 23F15E1682 23F15D1561 23F15C1091 23F15D0167 23F15B1878 23F15B0293 23F15A1295 23F15A0633 23F14M0574 23F14K1394 23F14K0462 23F14H1536 23F14G1210 23F14E0751 23F14B0822 23F13J1010 23F13J0221 23F13H0876 RF3065299 23F15F1564 23F15B2204 23F14H1433 23F14E0655 23F14E0173 23F14B1161 23F13K0564 23F14B0718 71F15D0580 71F15D1773 71F13J1276 71F13L0902 71F14C1183 71F14E1122 71F14K1663 71F14L0428 71F15A0864 71F15D1722 71F13L1104 71F13L0390 71F14A1957 71F14A0047 71F14C0588 71F14C1362 71F14G0670 71F14K1035 71F14K0409 71F14L1351 71F14L1201 71F14M0821 71F15B0782 71F15F1735 71F15C0829 71F15D0583 71F13J1277 71F14B0311 71F14D1628 71F14E1530 71F14H0659 71F14J1738 71F14L0743 71F14M0328 71F15A0161

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.

4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

Product Codes ASK-45552-RWJ3 CDC-35541-HPK1A EU-00750-45 PL-00750 AU-00420-MAJO CDC-35541-VPS EU-02041-ML PL-00755 CDC-34041-HPK1A CDC-35552-HPK1A EU-24041-HPMSB PR-35552-HPHNM CDC-34041-VPS CDC-35552-VPS EU-24052-HPMSB PR-45563-HPHNM CDC-34052-HPK1A CDC-41563-JX1A EU-25041-HPMSB UK-00420-MID CDC-34052-VPS CDC-44041-HPK1A EU-25052-HPMSB UK-00420-RCHT CDC-35041-HPK1A CDC-44052-HPK1A EU-25063-HPMSB UK-00420-THT CDC-35041-VPS CDC-44063-HPK1A EU-25541-HPMSB UK-04041-RDEH CDC-35052-HPK1A CDC-45063-HPK1A EU-25552-HPMSB UK-05041-MSB CDC-35052-VPS CDC-45563-HPK1A IB-01652 UK-05041-RDEH CDC-35063-HPK1A EU-00740-45 PL-00740 UK-05052-RCHT

General Hospital and Personal Use Devices

2

Yes

World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.

ARROW PICC Kit featuring Chlorag+ard Technology || Midline Catheterization Kit || ARROW Advantage5 Pressure Injectable PICC Kit || Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet || ARROW Pressure Injectable JACC with Chlorag+ard Technology || For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

Lot numbers: 73A1700701, 73H1600582, 73B1700183, 73H1600583, 73B1700567, 73H1600663, 73C1600069, 73H1600664, 73C1600070, 73H1600665, 73C1600071, 73H1600666, 73C1700288, 73H1600667, 73C1700289, 73H1600668, 73C1700290, 73J1600135, 73C1700292, 73J1600136, 73C1700300, 73J1600137, 73F1600036, 73J1600138, 73F1600037, 73J1600139, 73F1600038, 73J1600414, 73F1600039, 73J1600415, 73F1600040, 73J1600416, 73F1600689, 73K1600118, 73F1600690, 73K1600457, 73F1600691, 73K1600458, 73F1600692, 73K1600497, 73F1600693, 73K1600514, 73F1600694, 73K1600614, 73G1600151, 73L1600528, 73G1600431, 73L1600529, 73G1600432, 73L1600530, 73G1600716, 73L1600531, 73G1600717, 73L1600532, 73H1500014, 73L1600563, 73H1500015, 73M1600200, 73H1500016, 73M1600201, 73H1600173, 73M1600202, 73H1600174, 73M1600279

General and Plastic Surgery Devices

2

Yes

Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

CDC 34041 VPS Lot# 23F17A0037 23F17B0035

General Hospital and Personal Use Devices

2

Yes

AZ, CA, GA, MA, MO, NY, VA

ARROW¿ PICC || powered by ARROW¿ VPS¿ || Stylet

Lot numbers RF4088610 and RF4088406

General Hospital and Personal Use Devices

2

Yes

The products were shipped to hospitals in AZ, CA, NJ, and WV.

Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP