Reported Mar 8, 2017 · Terminated

Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic 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?

    • Basic Pack
    • part number AMS1868(B Basic Pack
    • part number AMS2608(A Basic Pack
    • part number AMS3861 Basic Pack
    • part number AMS4309 Basic Pack
    • part number PSS1833 Basic Pack
    • part number PSS1833(A Basic Pack
    • part number PSS1848(A
Lot codes and dates
  • 63 of 63 codes

    • Lot number and expiration date 100394
    • 9/15/2019 100593
    • 9/21/2019 100594
    • 10/5/2019 101063
    • 10/15/2019 101304
    • 10/23/2019 83725
    • 6/8/2018 84749
    • 9/11/2018 85159
    • 8/1/2018 85635
    • 8/6/2018 85810
    • 7/19/2018 86252
    • 9/2/2018 86440
    • 8/7/2018 86859
    • 8/18/2018 86939
    • 11/22/2018 87105
    • 9/15/2018 87269
    • 9/30/2018 87351
    • 9/15/2018 87447
    • 11/11/2018 87942
    • 9/23/2018 88172
    • 12/3/2018 88282
    • 9/7/2018 88368
    • 9/5/2018 88846
    • 12/11/2018 88887
    • 12/7/2018 89004
    • 10/8/2018 89160
    • 12/1/2018 89438
    • 11/22/2018 89512
    • 10/9/2018 89716
    • 1/9/2019 89743
    • 12/3/2018 89811
    • 12/1/2018 94572
    • 12/15/2018 94705
    • 12/15/2018 94751
    • 1/4/2019 94853
    • 1/27/2019 94935
    • 1/25/2019 95293
    • 1/26/2019 95412
    • 1/25/2019 95936
    • 1/11/2019 95974
    • 5/29/2019 96023
    • 1/16/2019 96255
    • 1/2/2019 96410
    • 3/7/2019 96566
    • 3/9/2019 96678
    • 5/24/2019 96913
    • 5/22/2019 97124
    • 5/12/2019 97410
    • 6/3/2019 97577
    • 5/1/2019 97780
    • 6/15/2019 98017
    • 6/29/2019 98312
    • 6/24/2019 98478
    • 6/29/2019 98502
    • 6/6/2019 98663
    • 6/28/2019 98633
    • 6/30/2019 99172
    • 6/12/2019 99581
    • 6/27/2019 99703
    • 9/27/2019 99843
Amount recalled
2388 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, 5:24 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.