FDAFDA · Food and drugs·Recall number Z-0896-2017
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
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 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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