Yes

Non-active implants - bone surgery

Yes

Implant

Yes

Implant

Lot#RL7054799, RL7044546, RL044529, RL7034289, RL7024171, RL7013848, RL6123738, RL6113609, RL6083023, RL6072946, and RL6062692.

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282, 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#RL7075217, RL7034341, RL7013847, RL6113498, and RL6093309

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322, 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# RL8016430, RL7105756, RL7085366, RL7034449, RL7034288, and RL7013906

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362, 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# RL6093219

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552, 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# RL6022012, RL5111395, RF5061635, and RF5072839

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, || The product is used for long term hemodialysis vascular access.USA

Lot# RL5111237, RL5111325, and RF5061636

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282, 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# RL5111238, RL5111377, and RF5072840

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322, 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# RL5121655

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, 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# RR6032277, RL5111326, and RF5061637

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552, 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# RL7054708, RL7044581, RL7034346, RL7034265, RL7024126, RL7013907, RL6123780, RL6113628, RL6103472, RL6083021, RL6082998, RL6072905, RL6072878, RL6062702, RL6052612, RL6042519, RL6032356, RL6022010, RL6011957, RL6011824, RL5121652, RL5111412, RL5101060, RL5090814, RF5084114, and RR5060807

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

Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-SP, 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# RL7075218, RL7064990, RL7064908, RL7054830, RL7044582, RL7034349, RL7034266, RL7024127, RL6123781, RL6113600, RL6103473, RL6103401, RL6103364, RL6083123, RL6083003, RL6072883, RL6062744, RL6052634, RL6052555, RL6042448, RL6032275, RL6022011, RL6011847, RL6011825, RL6011739, RL5121605, RL5121428, RL5111376, RL5090815, RF5072295, and RF5061643

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

Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, 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 #RL7075165, RL7064971, RL7044662, RL7034337, RL703420, RL7024049, RL7013953, RL6103343, RL6062812, and RL6062755.

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

Cannon¿ II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-VSP, 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 #RL7085440, RL7085404, RL7075211, RL7064954, RL7044506, RL7024090, RL7013829, RL6103375, RL6062769, and RL6062726.

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

Cannon¿ II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-VSP, 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# RL7095627, RL7095600, RL7085439, RL7075264, RL7075167, RL7065039, RL7034322, RL7024125, RL7013825, RL6103336, RL6062767, and RL6062747.

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

Cannon¿ II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-VSP, 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#RL7095524, RL7075134, RL7065041, RL7054792, RL7034390, RL7013965, RL6062819, and RL6062756.

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

Cannon¿ II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-VSP, 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# RL7075168, RL7054790, RL7024123, RL6093201, RL6083117, and RL6062757

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

Cannon¿ II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, 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# RL7065083, RL7064902, RL7054801, RL7024113, RL6103474, RL6093296, RL6083017, RL6082996, RL6062685, RL5101072, and RL5090957

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

Cannon¿ II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242-SP, 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#RL7085368, RL7075149, RL7044668, RL7034447, RL7013872, RL6113551, RL6103403, RL6082978, and RL5090961

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

Cannon¿ II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282-SP, 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 numbers: RF2095946, RF2056557, RF2058764, RF2060829,  RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837,  RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355,  RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821,  RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330,  RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution -- US and Canada.

The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. || The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.

Lot# RL7034372, RL6093298, RL6083063, RL6072900, and RL5090966.

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

Cannon¿ II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322-SP, 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 Number CS-15192-IXM, Lot Number RV1034909; Product Number CS-15232-IXM, Lot Number RV1034911; Product Number CS-15272-IXM, Lot Number RV1034912; Product Number CS-15312-IXM, Lot Number RV1034913; Product Number CS-15422-IX, Lot Number RV1034914; and Product Number CS-15502-IX, Lot Number RV1034915.

Gastroenterology-Urology Devices

2

Yes

United States (states of CA, DE, FL, MI, NC, and TN).

Arrow NextStep Antegrade Chronic Hemodialysis Catheter. || Product is used for attaining long-term vascular access for hemodialysis and apheresis.

Lot #RL7065076, RL7054704, RL7034338, RL6123772, RL6113608, RL6103456, and RL6062695.

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

Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, 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.