Device product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
Z-1327-2018
Product summary
- Event
- Event 79512
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1327-2018
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) 13F17D0187; (2) 13F17D0222, 13F17E0849
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.