FDAFDA · Food and drugs·Recall number Z-1323-2017
Laminectomy Pack, part number PSS1844(B
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 83287, 8/9/2017 87158, 7/10/2017 88004, 10/5/2017 88548, 10/14/2017 89055, 11/16/2017 89903, 12/28/2017 95142, 2/12/2018 95314, 2/9/2018 95839, 2/12/2018 96468, 3/26/2018 96630, 4/11/2018 96820, 6/12/2018 98748, 10/20/2017 99774, 6/24/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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