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