Reported Oct 26, 2016 · Terminated

Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating…

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?

  • Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Number/ Expiration Date

    64 of 64 codes

    • 67723
    • 11/19/2015
    • 61928
    • 11/20/2015
    • 56692
    • 7/19/2016
    • 67757
    • 7/22/2016
    • 58305
    • 8/6/2016
    • 58345
    • 8/14/2016
    • 69798
    • 9/14/2016
    • 69922
    • 9/16/2016
    • 69923
    • 9/29/2016
    • 58346
    • 10/4/2016
    • 70578
    • 10/11/2016
    • 68747
    • 10/12/2016
    • 69280
    • 10/23/2016
    • 70579
    • 12/5/2016
    • 70580
    • 12/26/2016
    • 70988
    • 3/23/2017
    • 73558
    • 4/24/2017
    • 74320
    • 5/24/2017
    • 74472
    • 5/25/2017
    • 75989
    • 7/16/2017
    • 77190
    • 7/21/2017
    • 76466
    • 7/22/2017
    • 74850
    • 7/23/2017
    • 76890
    • 7/23/2017
    • 75368
    • 7/30/2017
    • 76891
    • 8/4/2017
    • 76903
    • 8/10/2017
    • 77517
    • 8/29/2017
    • 77987
    • 9/5/2017
    • 77361
    • 10/10/2017
Amount recalled
2225 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, 6:14 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.