Reported Oct 26, 2016 · Terminated

Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general…

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, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers/ Expiration Dates
    • 62733
    • 11/3/2015
    • 62734
    • 11/11/2015
    • 63822
    • 11/15/2015
    • 63851
    • 1/1/2016
    • 64256
    • 1/3/2016
    • 64255
    • 1/13/2016
    • 63852
    • 4/2/2016
    • 69318
    • 7/14/2016
    • 69233
    • 7/18/2016
    • 69910
    • 9/17/2016
    • 70959
    • 12/6/2016
    • 70958
    • 1/3/2017
    • 73965
    • 1/9/2017
    • 73697
    • 1/20/2017
    • 73698
    • 1/23/2017
    • 75426
    • 5/18/2017
    • 73966
    • 5/20/2017
    • 76637
    • 6/11/2017
    • 76070
    • 6/30/2017
    • 78670
    • 8/13/2017
    • 78276
    • 9/30/2017
Amount recalled
1470 kits

This recall covers 150 products

The agency filed one notice per product. You are reading one of them; the other 149 are below.

137 more are in the archive.

Where it was sold

Why it was recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit 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 Oct 25, 2016 · 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.