Device product
Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
Z-1630-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 236 kits
- Official record key
device-enforcement:Z-1630-2017
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: 026403B Exp Date 2017-07-13; 029909B Exp Date 2017-12-08; 031012B Exp Date 2018-01-18; 031963B Exp Date 2018-03-01;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field