Device product
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Z-2193-2014
Product summary
- Event
- Event 68788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401,451
- Official record key
device-enforcement:Z-2193-2014
Official wording
Reason: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Code information: Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.