Reported Mar 8, 2017 · Terminated

Basic Kit, part number CMP1109(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?

  • Basic Kit, part number CMP1109(A
Lot codes and dates
    • Lot number and expiration date 84274
    • 5/14/2018 85771
    • 7/29/2018 86323
    • 9/5/2018 87540
    • 9/30/2018 88763
    • 12/2/2018 89683
    • 11/16/2018 95028
    • 1/5/2019 96659
    • 5/12/2019 97882
    • 6/4/2019 98262
    • 6/15/2019 99290
    • 9/27/2019
Amount recalled
216 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, 6:49 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.