# FDA recall Z-2244-2021

> **Cardinal Health 200, LLC** · Class I · device recall initiated 2021-06-16.

## Product

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811).  Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate.    Product Code: 43201

## Reason for recall

The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2244-2021
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-16
- **Report date:** 2021-08-25
- **Termination date:** 2023-01-04

- **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-2244-2021

## Citation

> AI Analytics. FDA recall Z-2244-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2244-2021. Source: US FDA. Licensed CC0.

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