Device product
Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
Z-1636-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92 kits
- Official record key
device-enforcement:Z-1636-2017
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: 030226A Exp Date 2017-10-30; 032172A Exp Date 2018-02-28; 032696A Exp Date 2018-03-30; 033176A Exp Date 2018-04-26;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field