Device product
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Z-0895-2017
Product summary
- Event
- Event 75746
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 35 cases
- Official record key
device-enforcement:Z-0895-2017
Official wording
Reason: 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.
Code information: Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016
Distribution pattern: PA, FL, VA
Derived failure modes
-
Unknown
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.