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Recall Observatory FDA recall evidence

Device product

(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

Z-1330-2018

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-1330-2018

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) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827

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.