Device product
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
Z-1648-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1056 kits
- Official record key
device-enforcement:Z-1648-2017
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: 027522B Exp Date 2017-03-30; 030020B Exp Date 2017-10-30; 031641B Exp Date 2017-12-30; 033142B Exp Date 2017-12-30; 034112B Exp Date 2018-04-30
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field