Device product
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
Z-1649-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 436 kits
- Official record key
device-enforcement:Z-1649-2017
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: 037464C Exp Date 2018-04-30; 038804C Exp Date 2018-04-30; 040546C Exp Date 2018-10-31
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field