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Open, Classified

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient

FDA Recall Z-0358-2023 · Posted 2022-12-02

Recalling FirmCardinal Health
Recall StatusOpen, Classified
Product CodeFCM
Date Initiated2022-11-01

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

Firm Action

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 [email protected], 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: [email protected] or call 800-292-9332.

Root Cause

Equipment maintenance

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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