Device product
Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
Z-1619-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 356 kits
- Official record key
device-enforcement:Z-1619-2017
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: 027750A Exp Date 2017-08-24; 028676A Exp Date 2017-10-13; 029916A Exp Date 2017-12-08; 030661A Exp Date 2018-01-04; 034835A Exp Date 2018-07-11;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field