PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 2, 2017 Initiated: June 27, 2017 #Z-2757-2017

Product Description

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.

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
1591 each
Distribution
Worldwide Distribution - US (Nationwide including PR) and Canada
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Cardinal Health 200, LLC. Units affected: 1591 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-2757-2017.