Arrow

  • Modèle / numéro de série
    Product No. AP-06535. Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636, MF6014780, MF6025930, MF6079639, MR2070141.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. The firm is NOT recalling from international accounts.
  • Description du dispositif
    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A(2) Port, 17 Fr. Introducer Kit || REF Product No. AP-06535
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
  • Source
    USFDA

570 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Product Number: AB-18040-N;  Lot Number:  RF2096425,  RF2010131,  RF1057898,  RF0074365,  RF0035689
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Modèle / numéro de série
  • Description du dispositif
    Implant Direct Sybron Manufacturing: InterActive® Implant Open-Tray Transfer Narrow
  • Manufacturer
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