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Recall Observatory FDA recall evidence

Device product

(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A

Z-1332-2018

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-1332-2018

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) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528

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.