Device product
Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
Z-1631-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 206 kits
- Official record key
device-enforcement:Z-1631-2017
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: 034978C Exp Date 2018-07-09; 038090C Exp Date 2018-09-12; 039153C Exp Date 2018-10-26;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field