Z-1574-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- January 9, 2017
- Termination Date
- September 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 704 kits
Product Description
Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
Reason for Recall
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.
Distribution Pattern
US Distribution to LA and TX.
Code Information
026598A Exp Date 2017-06-30; 028130A Exp Date 2017-07-30; 028918A Exp Date 2017-01-30; 029122A Exp Date 2017-09-30; 029906A Exp Date 2017-10-30; 031960A Exp Date 2018-01-30; 033019A Exp Date 2018-04-30;