Device product
Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
Z-1662-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 350 kits
- Official record key
device-enforcement:Z-1662-2017
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: 035042B Exp Date 2018-07-12; 038457B Exp Date 2018-09-23; 039618B Exp Date 2018-11-15
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field