Z-1938-2020 Class II Terminated
FDA device recall Z-1938-2020 was initiated by Argon Medical Devices, Inc on April 8, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 14, 2022). Affected quantity: 80.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 8, 2020
- Termination Date
- December 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
Code Information
Lot: 11299245