Reported Mar 8, 2017 · Terminated

Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B

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?

    • Laparoscopic Pack
    • part number AMS2499 Laparoscopic Pack
    • part number AMS2499(A Laparoscopic Pack
    • part number AMS2499(B
Lot codes and dates
    • Lot number and expiration date 84903
    • 7/25/2018 85836
    • 8/22/2018 86720
    • 9/30/2018 86873
    • 8/16/2018 87104
    • 8/30/2018 88049
    • 10/29/2018 88170
    • 10/5/2018 88378
    • 11/15/2018 88379
    • 12/2/2018 89576
    • 11/15/2018 89577
    • 12/2/2018 89721
    • 12/17/2018 94931
    • 1/29/2019 94932
    • 1/5/2019 95274
    • 1/27/2019 95596
    • 1/13/2019 95983
    • 6/10/2019 96593
    • 5/1/2019 97448
    • 5/28/2019 97653
    • 6/17/2019 97654
    • 6/24/2019 97655
    • 6/21/2019
Amount recalled
1056 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?

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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.