Reported Mar 8, 2017 · Terminated

Set-Up Pack, part number PSS1305(C

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 PSS1305(C
Lot codes and dates
    • Lot number and expiration date 100280
    • 9/22/2019 101104
    • 9/14/2019 84089
    • 6/29/2018 85293
    • 7/29/2018 85807
    • 8/21/2018 86209
    • 9/23/2018 86427
    • 8/9/2018 86627
    • 8/11/2019 87734
    • 9/29/2018 87934
    • 9/7/2018 87935
    • 11/21/2018 87936
    • 12/25/2018 87937
    • 12/29/2018 89476
    • 1/28/2019 95646
    • 1/10/2019 96062
    • 1/16/2019 96463
    • 3/8/2019 96464
    • 6/22/2019 96465
    • 5/28/2019 96466
    • 5/29/2019 96807
    • 6/6/2019 97610
    • 6/19/2019 97611
    • 6/17/2019 97878
    • 9/25/2019 97878
    • 9/25/2019 99195
    • 9/14/2019
Amount recalled
1275 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, 6:47 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.