FDAFDA · Food and drugs·Recall number Z-1361-2017
Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(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 101684, 8/21/2018 84576, 5/19/2017 87746, 10/15/2017 88702, 11/13/2017 89228, 10/1/2017 95000, 1/16/2018 96841, 1/8/2018 97168, 6/11/2018 97250, 7/15/2018 99100, 6/9/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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