The Recall Desk
HighFDA (Devices)·Z-1938-2020·Announced 2020-05-20

Argon Medical Devices Recalls PAC Tray Catheter Introducer Kits

Argon Medical Devices is recalling 80 PAC Tray/5 Catheter Introducer Trays due to incorrect needle and suture components 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 risk-of-harm product (needle stick injury) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Argon Medical Devices, Inc. is recalling 80 units of the PAC Tray/5 Catheter Introducer Tray 8F, Model 497424. The affected products are sterile, prescription-only medical devices indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. The specific lot number is 11299245.

The recall was initiated because the arterial line kits included 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, and the curved needle requires the use of a needle driver. There is a risk of needle stick if a surgeon attempts to manipulate the curved needle with fingers instead of using the required tool.

The products were distributed nationwide in the United States, including California, Illinois, North Dakota, South Carolina, Texas, and Virginia. No international distribution is reported. Healthcare providers and facilities should stop using the affected trays and contact Argon Medical Devices for further instructions.

The recalled product

Product
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for c
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
80

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: 11299245

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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