Device product
Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
Z-1628-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 kits
- Official record key
device-enforcement:Z-1628-2017
Official wording
Reason: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Code information: 028898B Exp Date 2017-10-19; 029882B Exp Date 2017-10-19; 031071B Exp Date 2018-01-25; 033617B Exp Date 2018-05-13;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field