Device product
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Z-1328-2018
Product summary
- Event
- Event 79512
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1328-2018
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 Number: 13F17F0081
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.