Device product
Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
Z-1543-2019
Product summary
- Event
- Event 82703
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1543-2019
Official wording
Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Code information: Batch Numbers: 3000045221 3000049201 3000054750 3000062046 3000065497 3000067793 3000069723 3000072247 3000075339 3000080720 3000084636
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured