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FDAFDA · Food and drugs·Recall number Z-1312-2017

Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G

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 84418, 1/30/2017 85478, 5/15/2017 85479, 5/21/2017 86212, 1/27/2017 86213, 1/27/2017 86630, 1/14/2017 87353, 1/24/2017 87946, 1/30/2017 88345, 2/22/2017 89564, 2/19/2017 94774, 1/17/2017 95066, 1/30/2017 95322, 1/25/2017 95854, 2/18/2017 96363, 2/10/2017 96634, 2/7/2018 97251, 2/7/2018 97325, 2/18/2018 98448, 2/10/2018 98449, 5/12/2018 98450, 10/24/2018 98451, 10/24/2018 98452, 10/31/2018 98453, 10/30/2018 98576, 10/20/2018 98577, 4/16/2019
Risk classification
Class II
Area (FDA)
device
Country
United States

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