Reported Oct 26, 2016 · Terminated

Major General Pack, Kit number 002645-11 and 002645-12 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 General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers Expiration Dates
    • 58579
    • 8/20/2013
    • 62097
    • 12/4/2013
    • 61593
    • 12/15/2013
    • 59838
    • 12/30/2013
    • 64762
    • 12/31/2013
    • 60645
    • 1/13/2014
    • 59179
    • 1/14/2014
    • 67196
    • 1/31/2014
    • 65990
    • 2/28/2014
    • 63190
    • 9/15/2014
    • 62540
    • 9/20/2014
    • 67875
    • 9/28/2014
    • 65484
    • 9/30/2014
    • 69395
    • 5/2/2016
    • 56674
    • 5/29/2016
    • 71054
    • 6/3/2016
    • 57460
    • 6/14/2016
    • 68944
    • 6/20/2016
    • 70475
    • 8/10/2016
Amount recalled
852 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, 6:04 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.