Device product
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Z-1646-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 kits
- Official record key
device-enforcement:Z-1646-2017
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: 029922D Exp Date 2017-10-30; 031037D Exp Date 2017-12-30; 032865D Exp Date 2018-3-30
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field