Device product
Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
Z-1663-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 kits
- Official record key
device-enforcement:Z-1663-2017
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: 031160C Exp Date 2018-01-22; 032881C Exp Date 2018-04-12
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field