Class 2 Device Recall Sterile Radial/Femoral Angiography Drape

• Date Initiated by Firm: May 21, 2021
• Create Date: July 08, 2021
• Recall Status: Terminated on January 08, 2024
• Recall Number: Z-2033-2021
• Recall Event ID: 88046
• Product Classification: Drape, surgical, exempt - Product Code PUI
• 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.
• Code Information: Lot Numbers: 20HGR063, 20JGR059, 20JGR068, 20JGR094, 20KGR048, 20LGR074
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: Customer Service; 888-444-5440
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 3192 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.