FDA Device

Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Hazard

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

What You Should Do

Remedy

The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units.

Products

Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from
Brand
Cardinal Health 200, LLC
UPC
Lot Numbers: 20LJS033, 20MJS072

Units Affected

574 units