Device product
Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
Z-1664-2019
Product summary
- Event
- Event 82703
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1664-2019
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: 3000076856 3000077891
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured