# FDA recall Z-0585-2020

> **Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.** · Class II · device recall initiated 2019-09-24.

## Product

4Fr x 20cm Single Lumen CT  Midline Basic Tray, Product Code: VYML4S1001

## Reason for recall

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT  Midline Basic Tray.

## Distribution

One Customer Located in TN

## Key facts

- **Recall number:** Z-0585-2020
- **Recalling firm:** Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-24
- **Report date:** 2019-12-04
- **Termination date:** 2020-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dover, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0585-2020

## Citation

> AI Analytics. FDA recall Z-0585-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0585-2020. Source: US FDA. Licensed CC0.

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