Z-2758-2017 Class II Terminated

Recalled by Cardinal Health 200, LLC — Waukegan, IL

Recall Details

Product Type
Devices
Report Date
August 2, 2017
Initiation Date
June 27, 2017
Termination Date
March 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
528 each

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.

Distribution Pattern

Worldwide Distribution - US (Nationwide including PR) and Canada

Code Information

Lot 16LUS317, expires November 1, 2021