Recall Z-1936-2020 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Argon Medical Devices, Inc
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
| 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 | 150 |
| 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
| K780871 | ARTERIAL LINE KIT Argon Medical Corp., Jun 14, 1978 |