Device product
Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
Z-1665-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 306 kits
- Official record key
device-enforcement:Z-1665-2017
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: 030684A Exp Date 2018-01-04; 032158A Exp Date 2018-03-11; 033365A Exp Date 2018-05-05; 034402A Exp Date 2018-06-20
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field