Recall Z-1938-2020 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Argon Medical Devices, Inc
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,
| Date | Apr 8, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Argon Medical Devices, Inc. sent Urgent Medical Device Recall letters, dated April 7, 2020 by mail on April 8th to the affected customer/hospital/distributors. The letter states they shipped Arterial Line Kits that include a different suture set than what is normally packaged in the kits the customers order. The kits customers normally order include a straight-cutting needle with a 3-0 silk suture. The kits customers recently received from them include a curved reverse-cutting needle with a 0-silk suture. A list of the affected product numbers is provided in the letter. They immediately co |
| Quantity | 80 |
| Distribution | US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH Argon Medical Corp., Mar 2, 1978 |