Z-1633-2017 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
- 71 kits
Product Description
Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
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
029238B Exp Date 2017-03-30; 030816B Exp Date 2017-11-30; 034258B Exp Date 2018-04-30;