Device product
Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
Z-1589-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 344 kits
- Official record key
device-enforcement:Z-1589-2017
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: 029709C Exp Date 2017-11-24; 029888C Exp Date 2017-12-07; 032207C Exp Date 2018-03-24; 033503C Exp Date 2018-05-11
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field