Device product
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Z-1677-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 670 kits
- Official record key
device-enforcement:Z-1677-2017
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: 026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field