Reported Oct 26, 2016 · Terminated

Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience…

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?

  • Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot numbers/Expiration dates

    108 of 108 codes

    • 59278
    • 10/2/2013
    • 58407
    • 10/14/2013
    • 62436
    • 12/4/2013
    • 62922
    • 12/18/2013
    • 60740
    • 5/20/2014
    • 63467
    • 6/2/2014
    • 62067
    • 6/7/2014
    • 64703
    • 6/10/2014
    • 61619
    • 6/14/2014
    • 64110
    • 6/14/2014
    • 63539
    • 6/29/2014
    • 65271
    • 7/8/2014
    • 65364
    • 7/11/2014
    • 65837
    • 7/31/2014
    • 70246
    • 9/3/2014
    • 70351
    • 9/4/2014
    • 69850
    • 9/7/2014
    • 67400
    • 9/11/2014
    • 69434
    • 9/18/2014
    • 71639
    • 9/18/2014
    • 68310
    • 9/30/2014
    • 72944
    • 10/1/2014
    • 71948
    • 10/9/2014
    • 71949
    • 10/22/2014
    • 65894
    • 2/7/2015
    • 68624
    • 3/12/2015
    • 77600
    • 8/12/2015
    • 76292
    • 8/14/2015
    • 72862
    • 10/5/2015
    • 73989
    • 10/7/2015
Amount recalled
1498 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, 4:45 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.