PlainRecalls
FDA Devices Moderate Class II Terminated

Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - 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.

Reported: July 14, 2021 Initiated: May 21, 2021 #Z-2035-2021

Product Description

Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - 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.

Reason for Recall

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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
1638 units
Distribution
US Nationwide distribution.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - 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.. Recalled by Cardinal Health 200, LLC. Units affected: 1638 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2035-2021.