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Recall Observatory FDA recall evidence

Device product

ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A

Z-1333-2018

December 22, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79512
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1333-2018

Official wording

Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information: Lot Numbers: (1) 13F17B0345, 13F17E0644, 13F17E0871, 13F17F0291; (2) 13F17B0124, 13F17B0355, 13F17E0727; (3) 13F16M0266, 13F17C0484, 13F17E0798; (4) 13F17B0037, 13F17E0451; (5) 13F17A0017, 13F17A0314, 13F17D0060, 13F17E0799, 13F17F0489

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.