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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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 Class 2 Device Recall Covidiensee related information
Date Initiated by FirmNovember 01, 2022
Date PostedDecember 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0359-2023
Recall Event ID 91087
510(K)NumberK903340 
Product Classification Tray, catheterization, sterile urethral, with or without catheter (kit) - Product Code FCM
ProductDover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Code Information UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364
Recalling Firm/
Manufacturer		 Cardinal Health
777 West St
Mansfield MA 02048-1122
For Additional Information ContactTodd King
847-596-3785
Manufacturer Reason
for Recall		Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
FDA Determined
Cause 2		Equipment maintenance
ActionCardinal Health issued Urgent Medical Device Recall Letter (Event-2022-04944) and Acknowledgement Form on November 1, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown in Attachment 1. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 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 GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product. 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 800-965-5227 " 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.
DistributionNationwide
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FCM
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