The Recall Desk
HighFDA (Devices)·Z-0358-2023·Announced 2022-12-14

Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying 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 with potential for clinically significant harm (urinary retention). This constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating per rubric criteria.

Plain-English summary

Cardinal Health is recalling Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter (14 Fr/Ch, Product Code 3410) nationwide. The recall involves potential occlusion (blockage) of the bubble inlet port of the urinary drainage bag, which may prevent urine from draining properly into the bag.

If the bladder is not emptied within a clinically appropriate time due to this blockage, there is an increased risk of urinary retention. Affected products are identified by lot numbers: 2216502164, 2215825764, 2215122964, 2213740864, 2209525264, and 2210223764. The UDI-DI is 10884521009448.

Healthcare facilities and patients should contact Cardinal Health or their healthcare provider regarding use of affected units. Report any adverse events or concerns related to this product to the FDA's MedWatch program.

The recalled product

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
Manufacturer
Cardinal Health
Category
Medical Device — Catheter / Urinary Drainage
Hazard

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 (5)

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

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

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Same hazard · blockage

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