Reported Mar 8, 2017 · Terminated

Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A

Windstone Medical Packaging, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521

Is this the product you have?

    • Upper Extremity Pack
    • part number AMS4670 Upper Extremity Pack
    • part number AMS4670(A
Lot codes and dates
    • Lot number and expiration date 100052
    • 9/16/2018 84369
    • 6/20/2017 84721
    • 6/26/2017 84951
    • 6/21/2017 85377
    • 7/26/2017 86594
    • 10/8/2017 86595
    • 10/11/2017 87312
    • 10/24/2017 87990
    • 10/6/2017 88277
    • 10/26/2017 88668
    • 11/1/2017 89203
    • 12/16/2017 89605
    • 12/17/2017 94907
    • 12/28/2017 94968
    • 12/5/2017 95303
    • 2/27/2018 95476
    • 2/20/2018 96326
    • 2/1/2018 96619
    • 2/10/2018 96788
    • 2/1/2018 96950
    • 1/5/2018 97302
    • 3/20/2018 97596
    • 4/28/2018 97819
    • 3/15/2018 98048
    • 3/24/2018 98529
    • 5/30/2018 98710
    • 6/10/2018 98945
    • 5/24/2018 98946
    • 6/7/2018
Amount recalled
1787 kits

This recall covers 124 products

The agency filed one notice per product. You are reading one of them; the other 123 are below.

111 more are in the archive.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 3, 2017 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.