Medical device recalls Moderate risk

Cardinal Health 200, LLC recalls Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drap…

Recall date
June 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2758-2017
FDA classification
Class II
Brand / firm
Cardinal Health 200, LLC
Sold / distributed
Worldwide Distribution - US (Nationwide including PR) and Canada

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, 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.

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