Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.
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: FDA Class II recall with no reported illnesses or injuries. The hazard poses a real risk of urinary retention if bladder emptying is delayed, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling specific lots of the Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (Product Code 2480), a medical device intended for urinary drainage from the bladder. The affected lot numbers are 2216501464, 2213046064, and 2206726764.
The urinary drainage bags in these trays may experience occlusion (blockage) of the bubble inlet port. This blockage may prevent urine from draining properly into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention.
The product has been distributed nationwide. Healthcare facilities and patients using affected lots should discontinue use and contact Cardinal Health for information about replacement products.
The recalled product
- 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
- Manufacturer
- Cardinal Health
- Hazard
- 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 (3)
- UDI-DI: Each 10884521009370 Case 20884521009377 Lot Numbers: 2216501464
- 2213046064
- 2206726764
Distribution
Distributed nationwide across the United States.
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