Z-0896-2017 Class II Terminated
FDA device recall Z-0896-2017 was initiated by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables on November 15, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 21, 2018). Affected quantity: US: 82 cases.
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: 82 cases
Product Description
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
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 1530330, Exp. Date November 2017; Lot Number 1530241, Exp. Date September 2017; Lot Number 1530095, Exp. Date September 2017; Lot Number 1431734, Exp. Date August 2017; Lot Number 1431066, Exp. Date May 2017