FDA-Device2017-08-02Class II
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.
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
1591 each
Manufactured in
1500 S Waukegan Rd, N/A, Waukegan, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2757-2017Don't want to check this manually?
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