Device product
Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
Z-1659-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 kits
- Official record key
device-enforcement:Z-1659-2017
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: 029296B Exp Date 2017-11-04; 030567B Exp Date 2017-12-29; 031350B Exp Date 2018-02-03; 033935B Exp Date 2017-06-30
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field