Device product
Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
Z-1591-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 456 kits
- Official record key
device-enforcement:Z-1591-2017
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: 031066A Exp Date 2018-01-21; 031996A Exp Date 2018-03-02; 033021A Exp Date 2018-04-19
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field