Arrow

  • Model / Serial
    Product No. AP-06016. Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372, MF4073836, MF4105283, MF6015284, MF6026177.
  • Product Classification
  • 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 Low Profile Port. 6 Fr. Introducer Kit. || Ref. Product No. AP-06016.
  • Manufacturer
  • 1 Event

Manufacturer

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

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    Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)Catalogue number: PI-01451-LSBatch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907ARTG Number: 148783
  • Manufacturer
  • Model / Serial
    Super Arrow-Flex Percutaneous Sheath Introducer SetSAP/Catalogue Numbers: CL-07635, CL-07735 and CL-07835Multiple batch numbers affectedARTG Number: 135922
  • Manufacturer
  • Model / Serial
    ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion KitsProduct Codes : IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-06830-U, IAB-06840-U and IAK-06845Multiple Batch Numbers affectedARTG Numbers: 101617, 106866 and 107249
  • Product Classification
  • Manufacturer
  • Model / Serial
    Various Kits containing Anticoagulant Citrate Dextrose Solution, Solution A (ACDA) 30mL Vials (Supplied in apheresis and surgical procedure kits)Affected kits:BIOCUE STD KIT ACD-A W/BDProduct Number: 800-0613A GPS3 SINGLE KIT W/BLOOD DRAWProduct Number: 800-0675A GPS BONE BIOLOGICS KIT 20mL + S.TUBEProduct Number: TCP20GPSS.2MARROWSTIM CALCIBON KIT 20mLProduct Number: TCP20MARROWBIOCUE CALCIBON KIT 20mLProduct Number: TCP20BIOCUE ARTG #: 183209, 100053, 127024
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