Z-2501-2021 Class II Ongoing
FDA device recall Z-2501-2021 was initiated by Argon Medical Devices, Inc on July 8, 2021 and is designated Class II. Reason for recall: As a result of design changes, sheaths have exhibited cracking/breaking at the tips. The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- July 8, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product 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.
Reason for Recall
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Distribution Pattern
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Code Information
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609