Device product
Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
Z-1671-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 454 kits
- Official record key
device-enforcement:Z-1671-2017
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: 028544D Exp Date 2017-10-06; 031310D Exp Date 2018-01-29; 031515D Exp Date 2018-03-29; 032531D Exp Date 2018-03-29; 034656D Exp Date 2018-06-28
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field