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Terminated

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.

FDA Recall Z-0294-2020 · Posted None

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDRS
Date Initiated2018-10-16
Date Terminated2021-06-15
Product QuantityTotal number in recall for all products in dist: 49,130 units

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.

Firm Action

The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.

Root Cause

Equipment maintenance

Distribution Pattern

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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