Device product
Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
Z-1555-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88 kits
- Official record key
device-enforcement:Z-1555-2017
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: 026556B Exp Date 2017-07-20; 029081B Exp Date 2017-10-23; 031679B Exp Date 2018-02-19; 032434B Exp Date 2018-03-24; 033616B Exp Date 2018-05-13;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field