Reported Oct 26, 2016 · Terminated

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A,…

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?

  • Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot codes/Expiration dates

    338 of 338 codes

    • 65013
    • 3/1/2014
    • 58261
    • 3/20/2014
    • 58964
    • 3/27/2014
    • 61857
    • 4/10/2014
    • 60968
    • 4/20/2014
    • 57095
    • 4/25/2014
    • 59002
    • 5/2/2014
    • 60388
    • 5/5/2014
    • 60299
    • 6/30/2014
    • 62798
    • 8/21/2014
    • 62654
    • 10/25/2014
    • 64447
    • 12/5/2014
    • 63072
    • 12/9/2014
    • 64328
    • 12/13/2014
    • 64679
    • 12/18/2014
    • 63368
    • 12/20/2014
    • 63799
    • 1/13/2015
    • 66644
    • 2/2/2015
    • 66509
    • 2/14/2015
    • 65777
    • 2/25/2015
    • 65573
    • 2/25/2015
    • 65718
    • 2/28/2015
    • 65875
    • 3/6/2015
    • 65572
    • 3/15/2015
    • 59027
    • 3/26/2015
    • 58692
    • 4/5/2015
    • 68613
    • 4/12/2015
    • 67175
    • 4/14/2015
    • 57249
    • 4/20/2015
    • 68069
    • 4/28/2015
Amount recalled
8132 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, 5:27 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.