Device product
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Z-1567-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 kits
- Official record key
device-enforcement:Z-1567-2017
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: 031483A Exp Date 2017-02-27; 034832A Exp Date 2017-12-03;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field