FDA-Device2021-07-14Class II
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - 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.
Cardinal Health 200, LLC
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.
Sold states
US Nationwide distribution.
Affected count
6461 units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2021Don't want to check this manually?
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