Device product
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Z-1545-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 kits
- Official record key
device-enforcement:Z-1545-2017
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: 029663A Exp Date: 2017-10-30; 031173A Exp Date 2018-01-25; 032155A Exp Date: 2018-02-28;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field