Reported Oct 26, 2016 · Terminated

Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom…

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?

  • Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot numbers/Expiration dates

    114 of 114 codes

    • 57968
    • 3/10/2014
    • 58335
    • 3/26/2014
    • 57096
    • 3/30/2014
    • 59915
    • 6/16/2014
    • 58966
    • 6/19/2014
    • 61731
    • 8/7/2014
    • 63240
    • 8/21/2014
    • 61024
    • 9/17/2014
    • 61499
    • 9/22/2014
    • 63588
    • 2/11/2015
    • 65772
    • 2/25/2015
    • 65779
    • 2/26/2015
    • 64225
    • 2/28/2015
    • 65239
    • 3/20/2015
    • 66645
    • 7/20/2015
    • 68070
    • 8/4/2015
    • 58830
    • 8/5/2015
    • 68893
    • 8/12/2015
    • 68265
    • 8/17/2015
    • 59541
    • 8/30/2015
    • 60650
    • 9/1/2015
    • 69806
    • 10/6/2015
    • 59840
    • 11/9/2015
    • 63811
    • 1/18/2016
    • 73766
    • 2/2/2016
    • 72807
    • 2/7/2016
    • 71917
    • 2/9/2016
    • 73424
    • 2/15/2016
    • 72515
    • 2/15/2016
    • 73401
    • 2/15/2016
Amount recalled
1528 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, 5:27 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.