Device product
Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
Z-1581-2019
Product summary
- Event
- Event 82703
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1581-2019
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: 3000041468 3000053105 3000054552 3000057683 3000059795 3000065086 3000067186 3000069077 3000071375 3000072684 3000074341 3000075431 3000078942 3000080722 3000081524 3000084050
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured