Z-2239-2023 Class II Ongoing

Recalled by Argon Medical Devices, Inc — Athens, TX

Recall Details

Product Type
Devices
Report Date
August 2, 2023
Initiation Date
June 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3.0

Product Description

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

Reason for Recall

There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

Distribution Pattern

US Nationwide distribution in the state of TX.

Code Information

Lot: 11481383, UDI: (00)886333217151