Device product
Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
Z-1661-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 kits
- Official record key
device-enforcement:Z-1661-2017
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: 030228A Exp Date 2017-12-23; 031467A Exp Date 2018-02-09; 032767A Exp Date 2018-04-07
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field