Reported Mar 8, 2017 · Terminated

Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G

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?

    • Hand Tray
    • part number PSS2365(F Hand Tray
    • part number PSS2365(G
Lot codes and dates
    • Lot number and expiration date 84418
    • 1/30/2017 85478
    • 5/15/2017 85479
    • 5/21/2017 86212
    • 1/27/2017 86213
    • 1/27/2017 86630
    • 1/14/2017 87353
    • 1/24/2017 87946
    • 1/30/2017 88345
    • 2/22/2017 89564
    • 2/19/2017 94774
    • 1/17/2017 95066
    • 1/30/2017 95322
    • 1/25/2017 95854
    • 2/18/2017 96363
    • 2/10/2017 96634
    • 2/7/2018 97251
    • 2/7/2018 97325
    • 2/18/2018 98448
    • 2/10/2018 98449
    • 5/12/2018 98450
    • 10/24/2018 98451
    • 10/24/2018 98452
    • 10/31/2018 98453
    • 10/30/2018 98576
    • 10/20/2018 98577
    • 4/16/2019
Amount recalled
1416 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, 5:28 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.