Device product
Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
Z-1667-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 kits
- Official record key
device-enforcement:Z-1667-2017
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: 026395B Exp Date 2017-07-13; 027756B Exp Date 2017-08-24; 030702B Exp Date 2018-01-05; 034442B Exp Date 2018-06-21
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field