Argon Medical Devices, Inc Recall 88520
Description: 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.
Argon Medical Devices, Inc Recall 88520 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2501-2021 |
| Event ID | 88520 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the state of WA. O.U.S.: N/A |
| Quantity | 20 units |
| Recall Reason | As a result of design changes, sheaths have exhibited cracking/breaking at the tips. |
| Device Classification | 20210929 |
| Device Code Info | Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609 |
| Center Classification Date | 20210921 |
| Recall Initiation Date | 20210708 |
| Recalling Firm | Argon Medical Devices, Inc |
| Initial Notification | Letter |
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