PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 2, 2017 Initiated: June 27, 2017 #Z-2758-2017

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
528 each
Distribution
Worldwide Distribution - US (Nationwide including PR) and Canada
Location
Waukegan, IL

Frequently Asked Questions

What product 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.. Recalled by Cardinal Health 200, LLC. Units affected: 528 each.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 2, 2017. Severity: Moderate. Recall number: Z-2758-2017.