Devices

Arrow

Model / Serial
Product No. AP-06520. Lot Number: MF1033516, MF2071649, MF2081937, MF2082002, MF2092208, MF2092278, MF2102373, MF2102462, MF2112595, MF2112688, MF2122960, MF3013060, MF3013065, MF3013198, MF3013279, MF3013308, MF3023367, MF3023427, MF3033567, MF3033642, MF3033732, MF3043847, MF3043910, MF3044134, MF3054228, MF3054338, MF3054447, MF3054465, MF3064645, MF3064763, MF3064833, MF3074927, MF3075118, MF3085281, MF3095491, MF3095574, MF3095611, MF3105931, MF3106006, MF3116245, MF3126277, MF3126278, MF3126318, MF3126396, MF3126417, MF3126450, MF4016582, MF4016635, MF4020551, MF4020553, MF4020806, MF4031020, MF4031582, MF4041771, MF4041936, MF4052333, MF4063058, MF4073792, MF4083964, MF4084041, MF4084292, MF4094582, MF4094706, MF4105124, MF4105261, MF4105486, MF4105803, MF4116118, MF5017414, MF5017549, MF5027701, MF5028033, MF5028158, MF5038602, MF5050176, MF5059737, MF5060355, MF5060468, MF5071341, MF5081670, MF5081671, MF5081762, MF5081870, MF5081902, MF5082122, MF5082249, MF5092841, MF5093006, MF5103341, MF5103508, MF5113683, MF5113875, MF5114153, MF5124319, MF5124528, MF6014777, MF6025871, MF6026069, MF6026200, MF6036711, MF6057765, MF6058113, MF6058190, MF6058298, MF6068660, MF6079304, MF6089737, MF6089985, MS3110155, MS3110156, MS3110157, MS3110158, MS4031056, MS4031058, MS4031059, MS4031065.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product Description
Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A Port, 10 Fr. Introducer Kit. || Ref Product No. AP-06520
Manufacturer
Arrow International Inc
1 Event
- Recall of Arrow

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

570 devices with a similar name

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Device Recall Arrow Nerve Block Component, Product Code: AB18040N

Model / Serial
Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution.
Product Description
Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or || analgesia techniques for periods not exceeding 72 hours.
Manufacturer
Arrow International Inc

Procedure packs containing various central venous catheters: pressure injectable, multi-lumen and...

Model / Serial
Product Description
Update to MDA/2014/022 . Procedure packs containing various central venous catheters: pressure injectable, multi-lumen and multi-lumen with Arrowg+ard ® antimicrobial surface. Specific product references and part numbers are affected. Check Appendix 2 of the FSN for the full list of additional affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FSQ1653 AR12854-MRI Manchester 4L CVC INS Pack 8.5Fr x 16cm FSQ1311 AR22854-HCH HCH 4L AGB CVC PACK 8.5FR 16CM FSQ372 AR22854-INSP INSP 16CM 4L AGB ARS CVC PACK FSQ1654 AR22854-MRI MANCHESTER ROYAL INFIRMARY AGBQUAD Northern Ireland: Manufacturer’s codes as in Appendix 2 of the FSN . Scotland SKU: Manufacturer’s codes as in Appendix 2 of the FSN . Wales NSV: Manufacturer’s codes as in Appendix 2 of the FSN .
Manufacturer
Arrow International (a division of Teleflex)

Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ar...

Model / Serial
Product Description
Central venous catheters: various pressure injectable, multi-lumen and multi-lumen with Arrowg+ard® antimicrobial surface. Specific product references and part numbers are affected. Check Appendix 1 of the FSN for the full list of affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FSQ489 BR-10854 8.5FR x 11cm set plus 3 way tap and scalpel FSQ607 BR-12854 8.5FR x 16cm Hi Flo with stop cocks FSQ443 BR-15854 8.5FR x 20cm set plus 3 way tap and scalpel FSQ965 BR-20854 8.5FR x 11cm Quad lumen antimicrobal CVC with 3 way stopcock FSQ609 BR-22854 8.5FR x 16cm anti-microbial Arrow Gard blue mid range set with stop cocks FSQ611 BR-25854 8.5FR x 20cm anti-microbial Arrow Gard blue mid range set with stop cocks FSQ599 CK-15854E 8.5FR x 20cm comprehensive pack FSQ545 CS-12854-E 8.5FR x 16cm set with Raulerson syringe FSQ444 CS-14854-E 8.5FR x 30cm set with Raulerson syringe FSQ1458 CS-15854-E 8.5FR x 20cm Quad-lumen central venous catheterization set with blue flextip catheter FSQ447 CS-22854-E 8.5FR x 16cm set with Raulerson syringe and Arrowgard plus blue antimicrobial surface treatment FSQ448 CS-25854-E 8.5FR x 20cm set with Raulerson syringe and Arrowgard plus blue antimicrobial surface treatment FSQ1461 CS-42854-E 8.5FR x 16cm 4 lumen central venous catheter with arrowg+ard blue plus antimicrobial technology. FSQ440 CV-12854 8.5FR x 16cm set FSQ441 CV-15854 8.5FR x 20cm set FSQ445 CV-22854 8.5FR x 16cm set with Arrowgard plus antimicrobial surface treatment FSQ446 CV-25854 8.5FR x 20cm set with Arrowgard plus antimicrobial surface treatment Northern Ireland: FVB000031 BR-15854 ARROW AKI BR-15854 4L CVC SET 8.5FR 20CM STOPCOCKS(5) FVB000024 BR-22854 ARROW AKI BR-22854 4L CVC SET AGB 8.5FR 16CM STOPCOCKS(5) FVB000025 BR-25854 ARROW AKI BR-25854 4L CVC SET AGB 8.5FR 20CM STOPCOCKS(5) FVB000028 CS-12854-E ARROW AKI CS-12854-E CATHETER QUAD LUMEN, 8.5FR, 16CM, WITHOUT COATING FVB000367 CS15854E ARROW AKI 4 LUMEN CVC SET ARS 8.5FR 20CM (5) FVB000029 CS-15854-E ARROW AKI CS-15854-E CATHETER QUAD LUMEN, 8.5FR, 20CM, WITHOUT COATING FVB000022 CS-22854-E ARROW AKI CS-22854-E CATHETER QUAD LUMEN, 8.5FR, 16CM,WITH ARROW GUARD FVB000023 CS-25854-E ARROW AKI CS-25854-E CATHETER QUAD LUMEN, 8.5FR, 20CM,WITH ARROW GUARD FVB000026 CV22854SR ARROW ACW CV22854SR 4L CVC SET AGB 8.5FR 16CM ONC Scotland SKU: 028030 BR-12854 CVC SET:4 LUMEN 8.5 FR X 16CM 137954 CS-22854-E CVC SET:4 LUMEN 8.5 FR X 16CM 083053 CS-25854-E CVC SET:4 LUMEN 8.5 FR X 20CM 061693 CV-12854 CVC SET:4 LUMEN 8.5 FR X 16CM 091065 CV-22854 CVC SET:4 LUMEN 8.5 FR X 16CM Wales NSV: Manufacturer’s codes as in Appendix 1 of the FSN .
Manufacturer
Arrow International (a division of Teleflex)

Various Arrow Critical Care devices

Model / Serial
Product Description
Please refer to the FSN and related Appendix for a complete list of affected products. Note that Devices marked as non-CE marked are not on the EU market.In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.
Manufacturer
Teleflex

InterActive® Implant Open-Tray Transfer Narrow

Model / Serial
Product Description
Implant Direct Sybron Manufacturing: InterActive® Implant Open-Tray Transfer Narrow
Manufacturer
Implant Direct Sybron Manufacturing

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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