Reported Mar 8, 2017 · Terminated

Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519

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 Setup Pack
    • part number AMS1787(A Basic Setup Pack
    • part number AMS6519
Lot codes and dates
    • Lot number and expiration date 101418
    • 10/9/2019 84727
    • 5/25/2018 85308
    • 6/3/2018 85485
    • 8/5/2018 86644
    • 9/11/2018 87420
    • 9/14/2018 88160
    • 11/15/2018 89015
    • 10/8/2018 89570
    • 12/1/2018 94914
    • 1/21/2019 94920
    • 1/12/2019 95736
    • 1/2/2019 96290
    • 1/28/2019 96902
    • 8/16/2020 99041
    • 9/25/2019
Amount recalled
276 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, 5:27 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.