Device product
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Z-2205-2014
Product summary
- Event
- Event 68788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401,451
- Official record key
device-enforcement:Z-2205-2014
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: Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016
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.