Recall Z-0294-2020— Argon Medical Devices, Inc
Class II · Terminated
Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2018-10-16, terminated 2021-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product..
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-16
- Terminated
- 2021-06-15
- Firm location
- Athens, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.