Reported Mar 8, 2017 · Terminated

Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder…

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?

    • Shoulder Pack
    • part number AMS2936 Shoulder Pack
    • part number AMS3638 Shoulder Pack
    • part number AMS3711(B Shoulder Pack
    • part numbere AMS4212 Shoulder Pack
    • part number AMS6460 Shoulder Pack
    • part numberPSS1852(A
Lot codes and dates
    • Lot number and expiration date 100412
    • 8/14/2018 100837
    • 10/19/2019 101181
    • 10/9/2019 83278
    • 5/27/2018 83634
    • 5/20/2017 84945
    • 6/24/2017 85147
    • 7/28/2017 85150
    • 7/15/2018 85258
    • 6/10/2018 85541
    • 7/14/2018 85554
    • 7/2/2018 85555
    • 7/7/2018 86259
    • 7/2/2017 86308
    • 9/20/2018 86488
    • 10/29/2018 86512
    • 9/28/2018 86688
    • 11/16/2019 86747
    • 8/3/2018 87122
    • 10/7/2017 87798
    • 10/28/2017 88399
    • 10/19/2017 88404
    • 11/20/2018 89040
    • 12/14/2017 89088
    • 12/10/2018 89598
    • 11/18/2018 89887
    • 12/16/2018 95111
    • 12/12/2017 95287
    • 6/15/2019 95811
    • 2/23/2018 96607
    • 1/7/2018 97133
    • 2/7/2018 97290
    • 5/22/2019 98325
    • 3/26/2018 98687
    • 6/14/2019 99065
    • 6/13/2018 99548
    • 9/27/2019
Amount recalled
875 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 4:46 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.