Reported Oct 26, 2016 · Terminated

Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in…

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?

  • Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot NumbersExpiration Dates
    • 58626
    • 10/25/2014
    • 61076
    • 5/14/2015
    • 62460
    • 6/4/2015
    • 63884
    • 6/6/2015
    • 63742
    • 6/11/2015
    • 65028
    • 6/12/2015
    • 63220
    • 6/18/2015
    • 66436
    • 11/27/2015
    • 65659
    • 11/30/2015
    • 57175
    • 5/16/2016
    • 67267
    • 5/17/2016
    • 72357
    • 5/25/2016
    • 72480
    • 7/21/2016
    • 78609
    • 1/17/2017
Amount recalled
312 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, 6:03 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.