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FDAFDA · Food and drugs·Recall number Z-1376-2017

Transvaginal Pack, part number CMP1767

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 85689, 7/24/2018 85859, 8/1/2018 86125, 11/14/2018 89073, 11/25/2018 89074, 11/22/2018 89211, 12/11/2018 89212, 12/3/2018 89273, 6/15/2019 97315, 5/6/2019 97489, 6/27/2019 98343, 6/10/2019 98344, 9/9/2019
Risk classification
Class II
Area (FDA)
device
Country
United States

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