FDA Recall
Terminated
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - 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.
Recall: Z-2034-2021
·
Initiated May 21, 2021
Recall
- Recall Number
- Z-2034-2021
- Event Number
- 88046
- Firm
- Cardinal Health 200, LLC
- FEI Number
- 3001236905
- Product Code
- PUI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 21, 2021
- Terminated
- January 8, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337
Description
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - 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
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.
Action
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.
Distribution
US Nationwide distribution.
Quantity
13426 units