Reported Oct 26, 2016 · Terminated

Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits…

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?

  • Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers/Expiration Dates

    70 of 70 codes

    • 59360
    • 4/4/2015
    • 60180
    • 7/22/2015
    • 60972
    • 8/20/2015
    • 60716
    • 9/20/2015
    • 61627
    • 10/15/2015
    • 65729
    • 11/15/2015
    • 65371
    • 11/18/2015
    • 62925
    • 11/26/2015
    • 64759
    • 12/26/2015
    • 63807
    • 1/14/2016
    • 64511
    • 1/16/2016
    • 65907
    • 7/11/2016
    • 57777
    • 7/16/2016
    • 67561
    • 8/26/2016
    • 69460
    • 9/11/2016
    • 69554
    • 11/9/2016
    • 72302
    • 1/5/2017
    • 71984
    • 1/27/2017
    • 73801
    • 4/2/2017
    • 74579
    • 4/23/2017
    • 78211
    • 4/26/2017
    • 74831
    • 5/23/2017
    • 74685
    • 5/24/2017
    • 74462
    • 5/25/2017
    • 74578
    • 5/26/2017
    • 75514
    • 7/2/2017
    • 77373
    • 7/19/2017
    • 78511
    • 8/6/2017
    • 75602
    • 9/19/2017
    • 79095
    • 11/4/2017
Amount recalled
1025 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.

Free recall alerts

Get alerted about new Windstone Medical Packaging, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 6:54 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.