Reported Oct 26, 2016 · Terminated

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(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?

  • Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Number/ Expiration Date

    155 of 155 codes

    • 61069
    • 1/5/2015
    • 57470
    • 1/15/2015
    • 64162
    • 1/20/2015
    • 66792
    • 1/31/2015
    • 61312
    • 2/27/2015
    • 66392
    • 2/27/2015
    • 59327
    • 4/24/2015
    • 60099
    • 7/15/2015
    • 61872
    • 7/26/2015
    • 60277
    • 8/24/2015
    • 60278
    • 8/24/2015
    • 61393
    • 9/7/2015
    • 63201
    • 9/15/2015
    • 61394
    • 10/14/2015
    • 62762
    • 11/3/2015
    • 61940
    • 11/17/2015
    • 62155
    • 11/23/2015
    • 64557
    • 11/27/2015
    • 61280
    • 11/27/2015
    • 61279
    • 11/28/2015
    • 61392
    • 11/30/2015
    • 66184
    • 12/24/2015
    • 65278
    • 12/27/2015
    • 63178
    • 1/3/2016
    • 63994
    • 1/13/2016
    • 64601
    • 1/13/2016
    • 64643
    • 1/17/2016
    • 63782
    • 1/23/2016
    • 63783
    • 1/23/2016
    • 73045
    • 1/29/2016
    (no date was provided)
Amount recalled
3104 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.

Free recall alerts

Get alerted about new Windstone Medical Packaging, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 6:16 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.