Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: 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 (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 →

Same manufacturer · Cardinal Health

See all →

High
Dover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
High
Dover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14
High
Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
High
Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
High
Dover Urinary Catheter Drainage Bag Port Occlusion Recall
FDA (Devices) · 2022-12-14

Same hazard · blockage