Device product
Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
Z-1658-2019
Product summary
- Event
- Event 82703
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1658-2019
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: (1)3000070816, 3000072682 (2) 3000074736, 3000077083, 3000080988, 3000082175 ***Updated 3/26/20*** Extended: 3000087051
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Sterility Assurance Level (SAL) of the stopcock ports cannot be assured