Reported Mar 8, 2017 · Terminated

Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

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?

    • Laparotomy Pack
    • part number 006268-9 Laparotomy Pack
    • part number AMS4418(A Laparotomy Pack
    • part number PSS2190(A
Lot codes and dates
    • Lot number and expiration date 100128
    • 9/28/2019 84856
    • 1/31/2019 86767
    • 12/22/2018 87491
    • 10/22/2017 88562
    • 10/20/2017 89958
    • 12/15/2018 94988
    • 12/5/2017 95849
    • 12/3/2017 96246
    • 3/3/2019 97441
    • 6/4/2019 97888
    • 6/16/2018 98626
    • 6/24/2019 98972
    • 7/22/2018 99473
    • 6/6/2019
Amount recalled
331 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, 5:22 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.