FDAFDA · Food and drugs·Recall number Z-1266-2017
Basic Kit, part number CMP1109(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 84274, 5/14/2018 85771, 7/29/2018 86323, 9/5/2018 87540, 9/30/2018 88763, 12/2/2018 89683, 11/16/2018 95028, 1/5/2019 96659, 5/12/2019 97882, 6/4/2019 98262, 6/15/2019 99290, 9/27/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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