Z-1599-2017 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
- 460 kits
Product Description
Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
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
038284E Exp Date 2018-09-20; 039282E Exp Date 2018-11-01;