Device product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Z-2207-2014
Product summary
- Event
- Event 68788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401,451
- Official record key
device-enforcement:Z-2207-2014
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: Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
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.