The Recall Desk
HighFDA (Devices)·Z-1937-2020·Announced 2020-05-20

Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect

Argon Medical Devices is recalling Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.

What this means for you

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: The recall involves a medical device with a risk of needle stick injury to healthcare workers. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Argon Medical Devices, Inc. is recalling Arterial Line Kits, Model 498106, due to a manufacturing defect. The affected kits include a thicker curved reverse-cutting needle with a 0-silk suture instead of the standard straight-cutting needle with a 3-0 silk suture.

The thicker suture may be more difficult to tie. Additionally, the curved needle requires the use of a needle driver; there is a risk of needle stick if a surgeon attempts to handle the needle with their fingers instead of using the driver.

The recall covers 20 units of Lot 11301012. Distribution was US Nationwide, including California, Illinois, North Dakota, South Carolina, Texas, and Virginia. Healthcare providers should stop using the affected kits and contact the manufacturer for instructions.

The recalled product

Product
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - 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:
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Catheters
Hazard
Affected units
20

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 (1)

  • Lot: 11301012

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Argon Medical Devices, Inc 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 3 products in this recall →

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Same manufacturer · Argon Medical Devices, Inc

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Same hazard · needle stick

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