Recall Z-2501-2021 ยท DYB Introducer, Catheter
Argon Medical Devices, Inc
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
| Date | Jul 8, 2021 |
| Status | Open, Classified |
| Reason | As a result of design changes, sheaths have exhibited cracking/breaking at the tips. |
| Root cause | Device Design |
| Action | On 07/08/2021, the firm's sales representative/clinical Specialist contacted via telephone to inform the single customer that the Recalling Firm was pausing evaluations of the affected device and was requesting return of the device. The customer was also informed that the Recalling Firm was in the process of implementing a few changes to improve upon the product. The product was place on hold at the customer's facility and the Recalling Firm's sales representative was picked up and returned to the Recalling Firm on 07/21/2021. |
| Quantity | 20 units |
| Distribution | U.S. Nationwide distribution in the state of WA. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set Argon Medical Devices, Inc., Jan 15, 2021 |