Events

Recall of Bard Access

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70430
  • Event Risk Class
    Class 2
  • Event Number
    Z-1271-2015
  • Event Initiated Date
    2014-08-08
  • Event Date Posted
    2015-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133596
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    Some unit packages of bd posiflush sf saline flush syringe 10 ml may exhibit open seals, which could impact product sterility. bard includes these pouched syringes, attached to some configurations of picc kits, port access kits (pak), powerglide kits, midline kits, and convenience kits.
  • Action
    The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.

Device

Bard Access
  • Model / Serial
    Lot Numbers: REXE1224, REYD1858, REXE0422, REXE0501, REYD0765, REYE1330, REYE1453, REXE0428, REXE0469, 13GB3687, REXD1150, 13HB2925, REYD1851, REXD1127, REYD1730, REXE0436, REXD1121, REXE0504, REXD1122, REXD1480, REXE0488, REXD1105, REYE1981, REXD1100, REXD1512, REXE0416, REXE0423, REXD1424, REYD1853, REXE0442, REXD2228, REXE0506, REXE1249, REXE1244, 13GB5123, REXD2243, REXD2244, REXD2221, REXD1507, REXD1159, REXE0724, 13GB3809, 13GB9452, 13HB0439, REYE0422, REXE0432, REXE1238, REYD1734, REXD1437, REXE1227, REYE0567, REXE0443, REXE1228, REXD1426, REXE0502, REXE1248, REYD1746, REXD1499, REXD1489, REXE0414, REXD1134, 13SB2585, 13GB3742, 13HB0440, REYD1986, REYD0634, REXE0448, REXD1147, REYD0718, REXD2246, REXE1260, REYE0645, REXE0481, REXD1154, REYE1472, REXD1155, REXD2225, REXE1247, REXE1917, 13KB1321, REYD0709, REYD1414, REXD1442, REXE0430, REXE0484, REXD1140, REXE0580, REXD1449, REXE0699, 13GB4430, 13HB9983, 13GB4431, REYD1342, REXD1441, REXE0498, REXD1148, REXD1440, REXE0483, REXE1295, reyd0573, REXD2233, REYE1465, REXE0462, REYD0630, REYD1865, REYD1744, REXD1481, REXE0528, REXE0812, REXC1785, REYE1467, REYE0591, REYD1747, REXD1128, reyd0521, 13SB2581, 13GB3737, 13SB2582, 12GB0338A, 13SB2578, 13SB0587, REXE0444, REYE1349, REXE0452, REXE0427, REXE1240, 13GB5446, 13KB1324, 13GB6046, REYE0912, REYE0907, REXD1471, REXD1473, REXE0475, REXE0446, REXE1229, REXD1452, REYD1742, REXE1234, 13GB3736, REXD1509, 13GB3738, 13SB2579, 13GB3741, 13GB3744, REXE0323, REYF1101, REXE0464, REXD1478, REXE0445, REXE1221, REXE0447, REXD1153, REYE0440, REXE0465, REXE0489, REXE1257, REXD1139, REXD2237, REYE0566, REXE0503, REXD1418, REXD1158, REXD1496, REYD1346, REYD1419, REXD1466, REXE1243, REYD1743, REXC1788, REYE0443, REXD1143, REXD2241, REXD2240, REXE0479, REXE0480, REXE1252, REYE0589, REYD1745, REXD1156, REYD1869, REXD1492, REXD1132, REXD1485, REXE0421, 13HB3413, 13HB3992, 13FB1090, 13GB9453, 13GB3684, 13SB3169, 13GB3798, 13GB4432, 13GB3801, 13GB4429, REYE0782, REXE0435, REXE1232, REXD1125, REXE1169, REXE0545, REXE1311, REYD1840, REYE0553, REXE0470, REYE0554, REXD2223, REXE0482, REXD1505, REXD1470, REXE0458, REXE0543, REXD1497, REXC1861, REXE0524, REXE0525, REXE1291, REYE1312, REYE1435, REXE0438, REXE0473, REXE0544, REXD1417, REYD1400, REXD1490, REYE0919, REYE1314, REYE0778, REXD2234, REXE0449, REXE0450, REXE0451, REXD2235, REXE0536, REYE0776, REXD1486, REXE0431, REXE0472, REXE0471, REXE0546, REXE1219, REYD0750, REYD1721, REYE0556, REXD1502, REXD2222, REXE0499, REXE1226, REYE0916, REYE0915, REYE1318, REXD2238, REXD2239, REXE0493, REXE0494, REXE0492, REXE0491, REXE0813, REXE0540, REXE0490, REXE1268, REXD1464, REXD1463, REYD1846, REYE1442, REXE0329, REXE1231, REXE0728, REXE0460, REYE0913, REXE0420, REXE0522, REXE1298, REYE0771, REXD1484, REXE0453, REXE0533, REXE1299, REYE0910, REYE1970, REXD1453, REXD2245, REXE0500, REXE1261, REXD1119, REXD1501, REXE0413, REYE0909, REYE0768, REXD1488, REXE0326, REXE0415, REXE0527, REXE1434, REXD0772, REXE0425, REXE0495, REXE1264, REXD1112, REXE0060, 13HB6959, 13KB1325, 13SB2586, 13KB0543, 13FB1089, 13RB1247, 13GB3683, 13GB3799, 13KB1326, 13SB2584, 13GB3739, 13KB0542, 13GB3740, 13GB3802, 13KB0545, 13GB3804, 13GB0155, 13HB0438, 13FB2112, 13FB8861, 13GB3743, 13GB3808, 13SB0588, 13IB3041, 13GB3685, 13GB3686, 13FB8863, 13GB3806, 13GB3797, 13GB8905, 13HB0436, 13GB3794, 13GB3795, 13GB3735, 13GB3796, 13GB8906, 13GB4481, REXD2198, REXD2199, REYE1980, REXD2218, REXD2216, REXD2220, REXD2219, REYD1982, REYE1979, REYE1978, 13GB8904, 13SB0036, 13SB0585, REYD1407, REYE0439, REXE0017, REXD1465, 13SB2580, REXD1104, REYE1803. Product Codes: 4153108 4153108D, 4154108D, CK000119A, 7927508D, CK000050A, 3175108, 3175108D, 3153108, 3154108, 3255108, CK000108, CK000109, CK000110, 7617407, 7617408, 7617408D, 3275108, 3275108D, 3275108FD, CK000036, CK000057, CK000099, CK000111, CK000206, 3386108, 3385108Q, 3385108QD, 3386108D, 9385108Q, 9385108QD, CK000145A, CK000207, CK000293, 9617407, 9617408, 9827507, 9827508, 9617408d, 9827508d, CK000235, 9153108, 9154108, 9254108, 9255108, CK000150, CK000294, 9175108, 9275108, 9276108, 9175108d, 9275108d, 9275108F, 9386108d, 9386108QD, CK000021, CK000082, CK000134, CK000216, CK000218, 9818508, 9818508d, 9918508D, CK000204, CK000205, 3174108, 9174108, 3174108D, 9174108d, CK000080, CK000098, CK000143, CK000165A, CK000178, CK000214, CK000269, CK000335, 3194108, 3295108, 3396108, 9194108, 9295108, 3295108d, 3295108F, 3395108Q, 3395108QD, 3396108D, 9194108D, 9295108d, 9295108f, 9295108FD, 9395108Q, 9395108QD, CK000044, CK000061, CK000071A, CK000097, CK000137, CK000138, CK000201, CK000253, CK000245, 1174108, 1175108, 1194108, 1275108, 1295108, 1386108, 9396108, 1174108D, 1175108D, 1194108D, 1275108D, 1275108f, 1275108fd, 1295108D, 1295108f, 1295108fd, 1385108D, 1385108Q, 1385108QD, 1386108D, 1395108Q, 1395108QD, 1396108D, CK0000103, CK000025, CK000026A, CK000127, CK000128, CK000129, CK000142, CK000155, CK000169A, CK000184, CK000186, CK000187A, CK000188A, CK000191, CK000192, CK000194, CK000220, CK000221, CK000222, CK000228A, CK000231, CK000232, CK000233, CK000241, CK000242, CK000252, CK000266, CK000267, CK000268, CK000283, CK000287, CK000291, CK000295, CK000296, CK000297, 3173108, 9173108, 3274108D, 9274108D, CK000215
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Manufacturer Address
    Bard Access Systems, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA