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U.S. Department of Health and Human Services

Class 2 Device Recall Nonsterile Radial/Femoral Angiography Drape

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  Class 2 Device Recall Nonsterile Radial/Femoral Angiography Drape see related information
Date Initiated by Firm May 21, 2021
Create Date July 08, 2021
Recall Status1 Terminated 3 on January 08, 2024
Recall Number Z-2034-2021
Recall Event ID 88046
Product Classification Drape, surgical, exempt - Product Code PUI
Product 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.
Code Information Lot Numbers: 2320DR1, 2330DR1, 2410DR1, 2440DR1, 2450DR1, 2580DR1, 2670DR1, 2730DR1, 2740DR1, 2790DR1, 2830DR1, 2860DR1, 2870DR1, 2890DR1, 2900DR1, 2930DR1, 2940DR1, 2950DR1, 3080DR1, 3310DR1, 3320DR1, 3330DR1, 3350DR1
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 2		 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 13426 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.
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