FDAFDA · Food and drugs·Recall number Z-1338-2017
Major Kit, part number PHC1307(A
Published March 8, 2017 · Recall initiated: January 11, 2017
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
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Lot
- Lot number and expiration date 84334, 6/8/2018 86584, 8/7/2018 89801, 1/24/2019 96122, 3/6/2019 97375, 6/2/2019 98632, 6/3/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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