Reported Oct 26, 2016 · Terminated

C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 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?

  • C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers/ Expiration Dates
    • 58207
    • 8/31/2013
    • 61591
    • 1/2/2014
    • 59228
    • 1/19/2014
    • 66522
    • 1/31/2014
    • 61763
    • 3/5/2014
    • 62929
    • 9/10/2014
    • 67485
    • 9/19/2014
    • 67664
    • 9/21/2014
    • 63835
    • 9/22/2014
    • 65290
    • 9/30/2014
    • 56956
    • 6/18/2016
    • 57666
    • 6/23/2016
    • 71060
    • 10/13/2016
    • 68943
    • 10/26/2016
    • 79065
    • 11/9/2017
    • 79842
    • 1/25/2018
    • 80908
    • 2/15/2018
Amount recalled
268 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, 6:04 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.