Reported Mar 8, 2017 · Terminated

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity…

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?

    • Extremity Pack
    • part number AMS3240 Extremity Pack
    • part number AMS4764 Extremity Pack
    • part number AMS4788(A Extremity Pack
    • part number PSS1798(A Extremity Pack
    • part number PSS1798(A Extremity Pack
    • part number PSS1798(A Extremity Pack
    • part number PSS1842(A Extremity Pack
    • part number PSS1842(A Extremity Pack
    • part number PSS1842(A Extremity Pack
    • part number PSS1842(A Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part numbre PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706 Extremity Pack
    • part number PSS2706(A Extremity Pack
    • part number PSS2706(A Extremity Pack
    • part number PSS2706(A Extremity Pack
    • part number PSS2706(A
Lot codes and dates
    • Lot number and expiration date 100226
    • 9/11/2019 101400
    • 10/7/2019 84373
    • 5/28/2018 84678
    • 6/8/2018 84896
    • 5/26/2018 84959
    • 7/29/2018 85470
    • 2/23/2017 85505
    • 7/23/2018 85547
    • 8/23/2018 85695
    • 7/8/2018 85846
    • 8/5/2018 86258
    • 9/19/2018 86509
    • 9/28/2018 86663
    • 8/11/2019 86686
    • 9/9/2018 86908
    • 9/13/2018 87155
    • 9/16/2018 87730
    • 7/5/2017 87968
    • 9/6/2018 88008
    • 7/1/2017 88862
    • 2/7/2018 89394
    • 11/15/2017 89546
    • 7/21/2017 89832
    • 12/29/2018 95313
    • 9/16/2019 95453
    • 1/22/2019 95880
    • 6/12/2019 96000
    • 1/6/2019 96383
    • 5/25/2018 96384
    • 5/13/2018 96923
    • 5/1/2019 97709
    • 5/1/2019 99376
    • 6/7/2019
Amount recalled
810 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, 4:47 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.