Z-0357-2023Class II

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm)

Name: Z-0357-2023 Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm)
Creator: Cardinal Health
Published: 2022-11-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-11-01 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health began a recall of Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a... on 2022-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0357-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-01
Posted: 2022-12-02
Recalling firm: Medtronic, Inc.
Product: Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
Product code: FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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.
Distribution: Nationwide
Product codes and lots: UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0357-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0356-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0357-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0358-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0359-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0360-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0361-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-02

Product code FCM

K903340Class IISterile Urethral Catheter Procedure KitsSuperior Healthcare Group, Inc. / cleared 1990-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)