Reported Oct 26, 2016 · Terminated

Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general…

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?

  • Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot numbers/Expiration dates
    • 62743
    • 8/18/2013
    • 57375
    • 9/5/2013
    • 58352
    • 9/13/2013
    • 58985
    • 1/28/2014
    • 62106
    • 7/14/2014
    • 61743
    • 7/21/2014
    • 63397
    • 12/21/2014
    • 63273
    • 12/26/2014
    • 64371
    • 3/13/2015
    • 64329
    • 3/21/2015
    • 66935
    • 4/22/2015
    • 67471
    • 5/11/2015
    • 68296
    • 9/19/2015
    • 68614
    • 9/27/2015
    • 68614
    • 9/27/2015
    • 70876
    • 10/12/2015
    • 69816
    • 10/14/2015
    • 70681
    • 10/20/2015
    • 71211
    • 10/21/2015
    • 71695
    • 10/26/2015
    • 73064
    • 12/20/2015
    • 72359
    • 12/24/2015
    • 77377
    • 1/19/2016
    • 76155
    • 1/25/2016
    • 81170
    • 7/8/2016
Amount recalled
546 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, 5:21 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.