Device product
Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
Z-1556-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 kits
- Official record key
device-enforcement:Z-1556-2017
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: 034433C Exp Date 2018-06-21; 039905C Exp Date 2018-12-01; 040125C Exp Date 2018-12-08;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field