Device product
Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
Z-1608-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 209 kits
- Official record key
device-enforcement:Z-1608-2017
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: 027181A Exp Date 2017-03-30; 030175A Exp Date 2017-03-30; 030570A Exp Date 2017-11-30; 031809A Exp Date 2017-12-30; 032419A Exp Date 2018-03-25; 033639A Exp Date 2018-03-30;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field