Reported Mar 8, 2017 · Terminated

Set Up Pack, part number PSS3574(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?

  • Set Up Pack, part number PSS3574(A
Lot codes and dates
    • Lot number and expiration date 100490
    • 8/7/2019 84969
    • 5/27/2018 85341
    • 6/15/2018 85566
    • 6/8/2018 86926
    • 8/2/2018 86927
    • 7/16/2018 87263
    • 10/10/2018 89647
    • 11/23/2018 89913
    • 10/2/2018 94889
    • 11/28/2018 95156
    • 11/14/2018 95674
    • 12/27/2018 96088
    • 1/25/2019 96849
    • 3/7/2019 96990
    • 5/7/2019 97637
    • 5/27/2019 98073
    • 5/23/2019 98373
    • 5/30/2019 99444
    • 6/24/2019
Amount recalled
820 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, 5:27 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.