Device product
Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
Z-1576-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248 kits
- Official record key
device-enforcement:Z-1576-2017
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: 027338B Exp Date 2017-05-30; 027664B Exp Date 2017-06-30; 028391B Exp Date 2017-07-30; 028752B Exp Date 2017-07-30; 029416B Exp Date 2017-09-30; 030580B Exp Date 2017-10-30; 032134B Exp Date 2018-01-30;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field