Device product
Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
Z-1550-201
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 kits
- Official record key
device-enforcement:Z-1550-201
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: 028743B Exp Date 2017-03-30; 030250B Exp Date 2017-08-01
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field