Argon Medical Devices Hemostasis Valve — Class II medical device recall Z-0294-2020
Terminated recall by Argon Medical Devices, Inc, reported 2019-11-13, distributed nationwide. The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the p
| Recall number | Z-0294-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2018-10-16 |
| Classified | 2019-11-05 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2021-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES, NL |
| Quantity | 49,130 units |
| Reason classes | sterility, packaging |
| Lot numbers | 11232311 |
| Model numbers | 049297 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0294-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.