Dover Urethral Catheter Drainage System Recall for Potential Port Blockage
Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing 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: This is an FDA Class II medical device recall involving a potential risk of patient harm from urinary retention if the drainage system fails. However, the source text does not report any illnesses or injuries, making the hazard theoretical. Per the rubric, risk-of-harm products where injury has not been reported score at 3 (High).
Plain-English summary
Cardinal Health is recalling the Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm), Product Code 3408. This medical device is intended for urinary drainage from the bladder of a patient. The recalled lot number is 2215825664, and the product was distributed nationwide.
The recall was issued because the bubble inlet port of the urinary drainage bag may become occluded (blocked), which may prevent urine from draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention in patients using the device.
The recalled product
- 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
- 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 (1)
- UDI-DI: Each 10884521009431 Case 20884521009438 Lot Numbers: 2215825664
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
Same manufacturer · Cardinal Health
See all →- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Urinary Catheter Drainage Bag Port Occlusion Recall
FDA (Devices) · 2022-12-14
- HighDover Urinary Catheter Drainage Tray Recall Due to Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
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FDA (Devices) · 2023-06-21
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FDA (Devices) · 2023-06-21