Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

U.S. FDA — Device Enforcement · United States · 2018-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0294-2020
Date of alert: 2018-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Argon Medical Devices, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11232311

Reported risk: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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 is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

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