FDAFDA · Food and drugs·Recall number Z-2025-2015
Shoulder Pack - contains Devon Light Glove Used during surgery
Published July 15, 2015 · Recall initiated: April 20, 2015
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stradis Healthcare, LLC.
- Distributor
- Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
- Lot
- Pack 888-2349
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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