Reported Mar 8, 2017 · Terminated

Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E

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?

    • Dr. Landi EVLT Pack
    • part number AMS1483(E Dr. Landi EVLT Pack
    • part number AMS1483(E
Lot codes and dates
    • Lot number and expiration date 100007
    • 2/26/2019 100008
    • 2/3/2019 100009
    • 2/10/2019 100322
    • 4/2/2019 101129
    • 2/21/2019 84854
    • 12/26/2017 85111
    • 12/1/2017 86047
    • 12/19/2017 86791
    • 5/7/2018 88616
    • 5/13/2018 88617
    • 6/11/2018 88845
    • 6/12/2018 89076
    • 10/22/2018 89175
    • 10/7/2018 89568
    • 11/9/2018 89715
    • 11/25/2018 94567
    • 10/23/2018 97120
    • 12/7/2018 97562
    • 11/27/2018 97771
    • 11/27/2018 98014
    • 11/11/2018 98014
    • 11/11/2018 98160
    • 2/22/2018 98161
    • 11/21/2018 98162
    • 11/30/2018 98494
    • 2/13/2019
Amount recalled
944 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, 5:25 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.