Device product
Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
Z-1644-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2016 kits
- Official record key
device-enforcement:Z-1644-2017
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: 027525B Exp Date 2017-08-14; 028915B Exp Date 2017-10-19; 030195B Exp Date 2017-12-21; 031255B Exp Date 2018-01-29; 032688B Exp Date 2017-09-30; 033330B Exp Date 2018-05-03
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field