# FDA recall Z-0357-2023

> **Cardinal Health** · Class II · device recall initiated 2022-11-01.

## 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

## Reason for recall

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0357-2023
- **Recalling firm:** Cardinal Health
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-01
- **Report date:** 2022-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2023

## Citation

> AI Analytics. FDA recall Z-0357-2023. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0357-2023. Source: US FDA. Licensed CC0.

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