Z-0294-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- October 16, 2018
- Termination Date
- June 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total number in recall for all products in dist: 49,130 units
Product Description
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Reason for Recall
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Distribution Pattern
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Code Information
Lot number 11232311