The Recall Desk

FDA (Devices) recall action 85488

Argon Medical Devices, Inc recalled 3 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-05-20
Critical
0
Units
250

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2020-05-20

    Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect

    Argon Medical Devices is recalling 150 Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.

    Product
    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:
    Category
    Distribution
    6 states
  • HighFDA (Devices)··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.

    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:
    Category
    Distribution
    6 states