FDAApril 8, 2020device

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 acce...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

argon medical devicesargonargon medical

UPCs

00886333214440

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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