Device product
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Z-1716-2015
Product summary
- Event
- Event 71093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,640,288
- Official record key
device-enforcement:Z-1716-2015
Official wording
Reason: Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
Code information: All lot numbers
Distribution pattern: Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
Derived failure modes
-
Unknown
Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber