Device product
Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
Z-1635-2019
Product summary
- Event
- Event 82703
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1635-2019
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: 3000041467 3000050581 3000055641 3000060358 3000067467 3000073974 3000083165
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured