Reported Mar 8, 2017 · Terminated

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry…

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?

    • Podiatry Pack
    • part number AMS2778 Podiatry Pack
    • part number AMS2778(A Podiatry Pack
    • part number AMS3785(B Podiatry Pack
    • part number AMS3785(C Podiatry Pack
    • part number AMS4011(A Podiatry Pack
    • part number PSS3422(A
Lot codes and dates
    • Lot number and expiration date 83685
    • 5/17/2018 84193
    • 5/20/2018 84520
    • 5/25/2018 84823
    • 6/30/2018 84892
    • 6/16/2018 85953
    • 7/29/2018 85991
    • 7/15/2018 85992
    • 7/23/2018 86060
    • 7/11/2018 86346
    • 7/30/2018 86419
    • 8/25/2018 87109
    • 8/15/2018 87789
    • 9/23/2018 87886
    • 10/29/2018 88300
    • 9/23/2018 88301
    • 9/30/2018 88313
    • 9/23/2018 88331
    • 10/11/2018 88332
    • 10/22/2018 88333
    • 10/25/2018 88630
    • 11/17/2018 88630
    • 11/17/2018 88707
    • 11/11/2018 88937
    • 6/28/2019 89028
    • 12/13/2018 95275
    • 1/19/2019 95598
    • 12/27/2018 95803
    • 1/11/2019 95989
    • 1/26/2019 96597
    • 3/24/2019 96916
    • 3/5/2019 97452
    • 3/21/2019 97580
    • 4/15/2019 97781
    • 4/22/2019 98022
    • 5/31/2019 98314
    • 5/29/2019 98668
    • 6/11/2019 98908
    • 7/24/2019 99873
    • 10/1/2019 99874
    • 6/4/2019
Amount recalled
2018 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, 4:53 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.