FDA-Device2017-08-02Class II

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.

Cardinal Health 200, LLC
Hazard

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.

Sold states
Worldwide Distribution - US (Nationwide including PR) and Canada
Affected count
528 each
Manufactured in
1500 S Waukegan Rd, N/A, Waukegan, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2758-2017

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