Z-2037-2021 Class II Terminated
FDA device recall Z-2037-2021 was initiated by Cardinal Health 200, LLC on May 21, 2021 and is designated Class II. 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. … The recall status is terminated (terminated January 8, 2024). Affected quantity: 5342 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- May 21, 2021
- Termination Date
- January 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5342 units
Product Description
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - 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 Pattern
US Nationwide distribution.
Code Information
a) 29460: Lot Numbers: 20LRS055, 20MRS073, 21ARS042 b) 29456: Lot Numbers: 20MMR062