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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health

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  Class 2 Device Recall Cardinal Health see related information
Date Initiated by Firm December 14, 2022
Date Posted January 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-0970-2023
Recall Event ID 91322
Product Classification Catheter, irrigation - Product Code GBX
Product Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
Code Information UDI/DI 50885380182448(cs), 20885380182447(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468 , N210543, N220050, N220099, N220139, N220163
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
Manufacturer Reason
for Recall		 Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown above. 2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: . Hospital 800-964-5227 . Federal Government 800-444-1166 . Distributor 800-635-6021 . All other customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Quantity in Commerce 921 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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