Reported Mar 8, 2017 · Terminated

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number…

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?

    • Open Procedure Pack
    • part number AMS4596 Open Procedure Pack
    • part number AMS4596(A Open Procedure Pack
    • part number AMS4596(B
Lot codes and dates
    • Lot number and expiration date 100206
    • 6/1/2018 100248
    • 7/9/2018 100438
    • 7/19/2018 100439
    • 8/29/2018 100853
    • 9/15/2018 86832
    • 10/10/2017 88268
    • 10/4/2017 89377
    • 11/9/2017 89378
    • 12/9/2017 94967
    • 12/31/2017 95888
    • 1/5/2018 96199
    • 2/11/2018 97018
    • 1/9/2018 97019
    • 2/17/2018 97146
    • 4/28/2018 97301
    • 3/22/2018 97478
    • 6/13/2018 98189
    • 5/20/2018
Amount recalled
1125 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.

Want the full recall guide?

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, 6:07 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.