Argon Medical recalls PAC Tray/5 Catheter Introducer Tray 8F Model 497424 due to curved needle requiring needle driver, risking needle sticks during surgery.
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.
Argon Medical is recalling a specific catheter introducer tray because its curved needle design requires a needle driver and increases the risk of needle sticks if a surgeon tries to use it with their fingers. This could lead to injury during surgical procedures.
The tray includes a thicker curved needle that requires a needle driver for safe use. If a surgeon tries to manually insert the needle without a driver, there is a risk of needle stick injuries.
Surgeons and medical professionals using this specific catheter introducer tray during arterial or venous procedures are most at risk. Patients undergoing surgery with this device may be affected.
Check for the model number 497424 on the tray. The product is sold as a sterile, Rx-only item for arterial and venous procedures. It was manufactured with a specific lot number.
Ensure the needle driver is used when inserting the curved needle to prevent needle stick injuries.
The product is safe when used with a needle driver, but there is a risk of needle sticks if used without one.
The model number is 497424.
Look for the model number 497424 on the tray, which is sold as a sterile, Rx-only item for arterial and venous procedures.
We’ve drafted a message you can send Argon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1938-2020 — Argon Medical Argon Medical Hello, I own a Argon Medical that is covered by recall Z-1938-2020 from Argon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.