Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PAC Tray/5 Catheter Introducer Tray 8F Recalled by Argon Medical Devices, Inc Due to Arterial Line Kits include thicker curved reverse-cutting needle...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.
Affected Products
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 contralateral access to the iliac artery and selected vasculature. Case Label: PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EO
Quantity: 80
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Argon Medical Devices, Inc
Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report