Dover Urinary Catheter Drainage Bag Port Occlusion Recall
Cardinal Health is recalling Dover closed urethral catheter trays due to potential occlusion of the 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 medical device recall with potential for serious clinical consequence (urinary retention). The source text explicitly states no illnesses or injuries have been reported, making this a theoretical hazard. Per the rubric, this qualifies as High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cardinal Health is recalling Dover Closed Urethral Tray with Vinyl Catheter (14 Fr, 5 mL, pre-connected to 1000 mL drainage bag, Product Code 3450LF) distributed nationwide. The recall involves lot numbers 2216806064, 2214452064, 2212401164, 2210219764, 2209525364, 2208816464, 2206737964, and 2206727564.
The bubble inlet port of the urinary drainage bag may become occluded (blocked), preventing urine from properly draining into the bag. If this blockage prevents timely emptying of the bladder, patients may experience urinary retention, which poses a risk of clinical complications.
Patients and healthcare providers using affected trays should discontinue use immediately and contact Cardinal Health. Any patient experiencing urinary retention or related symptoms should consult their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Cardinal Health
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 (6)
- UDI-DI: Each 10884521009585 Case 20884521009582 Lot Numbers: 2216806064
- 2214452064
- 2212401164 2210219764
- 2209525364
- 2208816464 2206737964
- 2206727564
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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See all →- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
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- HighDover urinary catheter drainage bag occlusion defect nationwide recall
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