Reported Mar 8, 2017 · Terminated

Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack,…

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?

    • Breast Pack
    • part number AMS3238(A Breast Pack
    • part number AMS4419(A Breast Pack
    • part number AMS4419(B Breast Pack
    • part number AMS5750 Breast Pack
    • part number AMS5750(A Breast Pack
    • part number AMS6120 Breast Pack
    • part number PSS1784(B Breast Pack
    • part number PSS2272(A
Lot codes and dates
    • Lot number and expiration date 100106
    • 6/21/2019 100129
    • 9/30/2019 100132
    • 6/17/2019 100505
    • 10/6/2019 100805
    • 9/21/2019 85140
    • 7/28/2018 86315
    • 11/19/2018 87053
    • 9/12/2018 87623
    • 8/10/2019 87945
    • 10/29/2018 88185
    • 12/1/2018 88827
    • 10/10/2018 89726
    • 12/10/2018 94942
    • 1/10/2019 96754
    • 5/20/2019 97548
    • 5/19/2019 98079
    • 6/1/2019 98319
    • 6/24/2019 99056
    • 6/27/2019 99157
    • 6/15/2019 99711
    • 9/4/2019
Amount recalled
369 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.

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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, 5:26 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.