Cardinal Health: 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

Agency Publication Date: December 2, 2022

Affected Products

Product: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

UDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764

Lot Numbers:

Numbers

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

UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

Lot Numbers:

Numbers

Product: 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

UDI-DI: Each 10884521009448 Case 20884521009445 Lot Numbers: 2216502164, 2215825764, 2215122964 2213740864, 2209525264, 2210223764

Lot Numbers:

Numbers

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

UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364

Lot Numbers:

Numbers

Product: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient

UDI-DI: Each 10884521009479 Case 20884521009476 Lot Numbers: 2216502264, 2216507864, 2215825864 2215119164, 2214451964, 2213740964 2213046464, 2212401364, 2212401264 2211101164, 2211101264, 2209515164 2210219664, 2209515264, 2209501064 2207800564, 2208816364, 2207401264 2207401164

Lot Numbers:

Numbers

Product: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.

UDI-DI: Each 10884521009585 Case 20884521009582 Lot Numbers: 2216806064, 2214452064, 2212401164 2210219764, 2209525364, 2208816464 2206737964, 2206727564

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91087

Status: Active

Manufacturer: Cardinal Health

Manufactured In: United States

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

UDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464, 2213046064, 2206726764

Lot Numbers:

Numbers

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

UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664

Lot Numbers:

Numbers

Product: 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

UDI-DI: Each 10884521009448 Case 20884521009445 Lot Numbers: 2216502164, 2215825764, 2215122964 2213740864, 2209525264, 2210223764

Lot Numbers:

Numbers

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

UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364

Lot Numbers:

Numbers

Lot Numbers:

Numbers

UDI-DI: Each 10884521009585 Case 20884521009582 Lot Numbers: 2216806064, 2214452064, 2212401164 2210219764, 2209525364, 2208816464 2206737964, 2206727564

Lot Numbers:

Numbers