Device product
Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
Z-1641-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 690 kits
- Official record key
device-enforcement:Z-1641-2017
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: 028113B Exp Date 2017-09-15; 030842B Exp Date 2018-01-11; 031792B Exp Date 2018-01-30
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field