Device product
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Z-1334-2018
Product summary
- Event
- Event 79512
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1334-2018
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) 13F17D0188, 13F17E0570; (2) 13F17E0660
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.