Device product
Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
Z-1598-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 834 kits
- Official record key
device-enforcement:Z-1598-2017
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: 027929B Exp Date 2017-08-30; 029240B Exp Date 2017-09-30; 030080B Exp Date 2017-10-30; 031818B Exp Date 2017-11-30;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field