Reported Oct 26, 2016 · Terminated

D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B 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?

  • D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Lot codes and dates
  • Lot Numbers/ Expiration Dates
    • 75712
    • 3/11/2016
    • 69832
    • 3/14/2016
    • 74687
    • 3/16/2016
    • 71295
    • 3/21/2016
    • 74077
    • 3/23/2016
    • 70789
    • 3/25/2016
    • 74537
    • 3/25/2016
    • 75697
    • 3/25/2016
    • 79345
    • 3/26/2016
    • 73305
    • 3/28/2016
    • 75819
    • 3/30/2016
    • 78202
    • 3/30/2016
Amount recalled
615 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?

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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, 4:45 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.