Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a mechanical malfunction that could lead to urinary retention if not managed timely. No illnesses or injuries have been reported, and the hazard is preventable through appropriate clinical management. Per rubric criteria, absence of reported harm with a theoretical hazard warrants a High severity rating.
Plain-English summary
Cardinal Health is recalling the Dover Closed Urethral Tray with Vinyl Catheter (Product Code 3420) nationwide. The urinary drainage system is intended for urinary drainage from the bladder of patients.
The bubble inlet port of the urinary drainage bag may become occluded (blocked), preventing urine from flowing into the bag. If the bladder is not emptied within a clinically appropriate time, this blockage may increase the risk of urinary retention.
The recall affects units with Lot Number 2215000364. Each unit has UDI-DI 10884521009455, and cases have UDI-DI 20884521009452. The affected product was distributed nationwide.
The recalled product
- Product
- Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
- Manufacturer
- Cardinal Health
- Hazard
- drainage-blockage
- urinary-retention
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: Each 10884521009455 Case 20884521009452 Lot Numbers: 2215000364
Distribution
Distributed nationwide across the United States.
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