Device product
Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
Z-1638-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,000 kits
- Official record key
device-enforcement:Z-1638-2017
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: 028131A Exp Date 2017-09-16; 028606A Exp Date 2017-10-13; 029244A Exp Date 2017-11-02; 029917A Exp Date 2017-12-08; 030686A Exp Date 2018-01-04; 031323A Exp Date 2018-02-01; 031824A Exp Date 2018-02-24; 032567A Exp Date 2018-03-31; 033054A Exp Date 2018-04-21; 033680A Exp Date 2018-05-19;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field