Z-2757-2017 Class II Terminated
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
- 1591 each
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.
Distribution Pattern
Worldwide Distribution - US (Nationwide including PR) and Canada
Code Information
Lot 16LFS235, expires November 1, 2021