—#196700

Product

Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient

FDA product code: FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K903340
Affected lot / code info: UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Cardinal 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.

Recalling firm

Firm: Cardinal Health
Address: 777 West St, Mansfield, Massachusetts 02048-1122

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-11-01
Posted by FDA: 2022-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.