FDAFDA · Food and drugs·Recall number Z-0894-2017
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Published December 28, 2016 · Recall initiated: November 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
- Distributor
- PA, FL, VA
- Lot
- Lot Number 1230783, Exp. Date February 2017; Lot Number 1330825, Exp. Date April 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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