Z-0895-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 15, 2016
- Termination Date
- June 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 35 cases
Product Description
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Reason for Recall
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Distribution Pattern
PA, FL, VA
Code Information
Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016