FDA Device recall Z-0294-2020
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which i…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which i… by Argon Medical Devices, citing the seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0294-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
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.
Identifiers
| code_info | Lot number 11232311 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0294-2020%22
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