Device product
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Z-1655-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 288 kits
- Official record key
device-enforcement:Z-1655-2017
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: 028912A Exp Date 2017-10-16; 030725A Exp Date 2018-01-08; 031994A Exp Date 2018-03-02; 033625A Exp Date 2018-02-20
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field