Reported Mar 8, 2017 · Terminated

Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number…

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?

    • Hand Pack
    • part number AMS3640 Hand Pack
    • part number AMS4213(A Hand Pack
    • part number AMS4311(A Hand Pack
    • part number AMS5343 Hand Pack
    • part number PSS1843(A
Lot codes and dates
    • Lot number and expiration date 100610
    • 8/6/2018 84646
    • 5/12/2017 84692
    • 7/28/2017 84730
    • 5/18/2017 84851
    • 6/1/2017 84859
    • 2/28/2017 85509
    • 7/1/2017 86309
    • 8/26/2018 86748
    • 8/17/2018 86839
    • 8/2/2018 86937
    • 10/14/2017 87631
    • 10/5/2017 87866
    • 9/15/2018 88208
    • 4/6/2017 88209
    • 7/31/2017 88266
    • 10/29/2018 88267
    • 1/5/2020 88279
    • 1/3/2019 88402
    • 11/2/2017 88875
    • 10/31/2017 89734
    • 12/16/2017 94987
    • 3/21/2018 95112
    • 2/2/2018 96198
    • 2/10/2018 96608
    • 1/7/2018 97288
    • 2/7/2018 97796
    • 5/6/2018 98564
    • 3/19/2018 99383
    • 5/11/2018
Amount recalled
102 6 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?

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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, 4:49 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.