Reported Aug 2, 2017 · Terminated

Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan,…

Cardinal Health 200, LLC

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: Cardinal Health 200, LLC · 1500 S Waukegan Rd · Waukegan, IL · 60085-6728

Is this the product you have?

  • Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Lot codes and dates
    • Lot 16LFS235
    • expires November 1
    • 2021
Amount recalled
1591 each

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

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 Mar 29, 2019 · Data as of Sep 19, 4:52 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.