Device product
Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
Z-1554-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320 kits
- Official record key
device-enforcement:Z-1554-2017
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: 037143E Exp Date 2018-08-05; 038259E Exp Date 2018-09-19; 040326E Exp Date 2018-12-14;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field