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FDAFDA · Food and drugs·Recall number Z-1308-2017

General Surgery Pack, part number PSS1380(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 84680, 5/19/2018 85462, 8/6/2018 86849, 8/16/2018 87483, 8/11/2019
Risk classification
Class II
Area (FDA)
device
Country
United States

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