Reported Oct 26, 2016 · Terminated

Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital…

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?

  • Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers/ Expiration Dates
    • 59180
    • 8/13/2013
    • 58144
    • 11/7/2013
    • 63191
    • 12/3/2013
    • 62098
    • 12/6/2013
    • 61064
    • 12/13/2013
    • 61592
    • 12/16/2013
    • 63809
    • 12/17/2013
    • 62398
    • 12/19/2013
    • 60127
    • 12/20/2013
    • 59454
    • 1/25/2014
    • 66802
    • 1/31/2014
    • 67030
    • 1/31/2014
    • 59839
    • 2/16/2014
    • 61296
    • 2/21/2014
    • 65291
    • 2/28/2014
    • 68567
    • 9/5/2014
    • 62930
    • 9/20/2014
    • 67877
    • 9/21/2014
    • 64458
    • 9/30/2014
    • 71056
    • 10/11/2015
    • 68946
    • 10/26/2015
    • 69206
    • 5/10/2016
    • 69631
    • 5/23/2016
    • 70482
    • 5/29/2016
    • 71057
    • 6/4/2016
    • 57292
    • 6/11/2016
    • 57780
    • 6/23/2016
Amount recalled
1200 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.

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 Oct 25, 2016 · Data as of Sep 19, 4:47 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.