Z-2239-2023 Class II Ongoing
FDA device recall Z-2239-2023 was initiated by Argon Medical Devices, Inc on June 8, 2023 and is designated Class II. Reason for recall: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. The recall status is ongoing. Affected quantity: 3.0.
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