Reported Mar 8, 2017 · Terminated

Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part…

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?

    • Custom Pack
    • part number AMS4776 Custom Pack
    • part number AMS4776(A Custom Pack
    • part number AMS5643 Custom Pack
    • part number AMS5643(A Custom Pack
    • part number AMS6012 Custom Pack
    • part number AMS6383 Custom Pack
    • part number PSS2135(B Custom Pack
    • part number PSS2798(B Custom Pack
    • part number PSS2798(C Custom Pack
    • part number PSS3463
Lot codes and dates
  • 65 of 65 codes

    • Lot number and expiration date 100084
    • 10/2/2019 100678
    • 10/22/2019 100683
    • 10/13/2019 100700
    • 9/5/2019 100771
    • 7/9/2019 100772
    • 7/23/2019 101188
    • 9/6/2019 101555
    • 9/9/2019 84253
    • 5/12/2018 84254
    • 5/25/2018 84377
    • 9/10/2018 84493
    • 5/28/2018 84494
    • 5/28/2018 84495
    • 6/22/2018 84681
    • 7/22/2018 84682
    • 7/29/2018 84853
    • 7/22/2018 84919
    • 6/3/2018 86006
    • 8/22/2018 86135
    • 9/29/2018 86853
    • 10/31/2018 87162
    • 8/10/2019 87171
    • 8/20/2018 87229
    • 10/5/2018 87582
    • 12/28/2018 87615
    • 12/17/2018 88006
    • 9/23/2018 88227
    • 9/5/2018 88559
    • 11/14/2018 88573
    • 11/12/2018 88574
    • 11/14/2018 88692
    • 2/28/2018 88693
    • 12/9/2018 88899
    • 11/24/2018 89221
    • 12/7/2018 89554
    • 12/9/2018 89555
    • 1/6/2019 89762
    • 1/10/2019 94731
    • 11/12/2018 95058
    • 1/18/2019 95061
    • 1/13/2019 95477
    • 12/7/2018 95510
    • 1/25/2019 95631
    • 3/7/2019 95654
    • 1/10/2019 95874
    • 6/27/2019 96054
    • 1/13/2019 96361
    • 3/10/2019 96458
    • 1/25/2019 96477
    • 1/25/2019 96478
    • 6/23/2019 96834
    • 6/10/2019 96988
    • 6/9/2019 97000
    • 6/29/2019 97166
    • 5/11/2019 97547
    • 5/7/2019 97820
    • 6/7/2019 98230
    • 6/8/2019 98588
    • 6/7/2019 98753
Amount recalled
4155 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.