# FDA recall Z-1936-2020

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2020-04-08.

## Product

Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI:  00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required.    Case Label:  Arterial Line Kit 20ga x 3", Ref 498411B, Qty:  10/CS

## Reason for recall

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture.  The thicker suture may be more difficult to tie.  The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

## Distribution

US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS:  None

## Key facts

- **Recall number:** Z-1936-2020
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-08
- **Report date:** 2020-05-20
- **Termination date:** 2022-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1936-2020

## Citation

> AI Analytics. FDA recall Z-1936-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1936-2020. Source: US FDA. Licensed CC0.

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