FDA recall Z-2033-2021

Cardinal Health 200, LLC · Class II · device

Product

Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - 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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-05-21
Report date
2021-07-14
Termination date
2024-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2033-2021