FDAFDA · Food and drugs·Recall number Z-1345-2017
Morris Hysto Pack, part number PSS3198(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 101121, 10/5/2019 101680, 10/27/2019 83882, 7/8/2018 87088, 8/16/2018 87496, 9/24/2018 88351, 11/11/2018 89549, 12/22/2018 94996, 1/30/2019 97899, 6/15/2019 98769, 6/25/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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