Reported Mar 8, 2017 · Terminated

Ortho Minor Pack, part number AMS3710(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?

  • Ortho Minor Pack, part number AMS3710(A
Lot codes and dates
    • Lot number and expiration date 100234
    • 9/8/2019 84944
    • 6/4/2018 85366
    • 7/23/2018 85662
    • 9/29/2018 86669
    • 9/15/2018 87127
    • 11/21/2018 89042
    • 12/12/2018 89735
    • 11/12/2018 95813
    • 1/28/2019 96010
    • 1/26/2019 97466
    • 5/28/2019 98514
    • 6/30/2019 99386
    • 6/10/2019
Amount recalled
664 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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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, 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.