Reported Mar 8, 2017 · Terminated

Custom Pack - with Introducer Kit, part number TVS4011NI(L

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?

  • Custom Pack - with Introducer Kit, part number TVS4011NI(L
Lot codes and dates
    • Lot number and expiration date 85014
    • 4/30/2018 85448
    • 7/14/2018 85937
    • 8/23/2018 87713
    • 8/9/2018 88092
    • 11/18/2018 89342
    • 10/17/2018 89974
    • 12/5/2018 95212
    • 12/3/2018 95725
    • 12/19/2018 96882
    • 12/9/2018 97051
    • 5/27/2019 98088
    • 5/2/2019 98423
    • 5/25/2019 98852
    • 5/14/2019
Amount recalled
840 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, 5:22 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.