Device product
Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
Z-1563-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 kits
- Official record key
device-enforcement:Z-1563-2017
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: 030249E Exp Date 2017-07-30; 031452E Exp Date 2017-07-30;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field