Device product
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Z-1672-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 212 kits
- Official record key
device-enforcement:Z-1672-2017
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: 037619E Exp Date 2018-08-23; 038962E Exp Date 2018-10-20; 039792E Exp Date 2018-11-29
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field