Device product
Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
Z-1657-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216 kits
- Official record key
device-enforcement:Z-1657-2017
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: 026440A Exp Date 2017-07-16; 030021A Exp Date 2017-12-11; 030186A Exp Date 2017-12-21; 031464A Exp Date 2018-02-15; 032390A Exp Date 2018-03-22; 033782A Exp Date 2018-05-20
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field