Device product
Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
Z-1559-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 156 kits
- Official record key
device-enforcement:Z-1559-2017
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: 027749A Exp Date 2017-08-21; 028525A Exp Date 2017-10-02; 029878A Exp Date 2017-10-30; 032596A Exp Date 2018-02-28; 034309A Exp Date 2018-06-17; 035003A Exp Date 2018-07-11;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field