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.
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Contact the company
📍Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/65460-argon-medical-pac-tray-5-catheter-introducer-tray-8f-recall.
“Argon Medical PAC Tray 5 Catheter Introducer Tray 8F Recall: Curved Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65460-argon-medical-pac-tray-5-catheter-introducer-tray-8f-recall. Based on FDA recall #Z-1938-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1938-2020%22&limit=1).
Argon Medical Devices, Inc. voluntarily recalled PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, on April 8, 2020, according to the FDA. The recall addresses a hazard involving incorrect needle and suture components in arterial line kits that pose a risk of needle stick injuries.
How to tell if you have it
Brand: Argon Medical
Product: PAC Tray/5 Catheter Introducer Tray 8F
Model Number: 497424
UDI: 00886333214440
Lot Code: 11299245
The hazard
The arterial line kits include a thicker curved reverse-cutting needle with a 0-silk suture instead of the usual straight-cutting needle with a 3-0 silk suture, according to the FDA. The thicker suture may be more difficult to tie, and the curved needle requires a needle driver, creating a risk of needle stick if the surgeon attempts to use fingers.
Context
GovInfoNow's records show Argon Medical Devices, Inc. has 15 other recalls on record since October 16, 2018. Other recent recalls of similar products include Medline Urethral Catheter Tray Recall (May 4, 2026), Rocket 18Fg Seldinger Catheter Tray (November 7, 2025), and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (November 6, 2025).
How to tell if you have this one
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.
Brand
Argon Medical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
Recall number
Product, codes & lots
Quantity
Z-1936-2020
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; Lot: 11299236
150
Z-1937-2020
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: Arterial Line Kit/1 20ga x 3", Qty: 10/CS, CE 2797; Lot: 11301012
20
Z-1938-2020
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; Lot: 11299245
80
Based on the official FDA remedy
What to do — step by step
Check for Needle Driver Use
Ensure the needle driver is used when inserting the curved needle to prevent needle stick injuries.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, North Dakota, South Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1938-2020 (April 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1938-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.