—#175982

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.

FDA product code: DRS — Transducer, Blood-Pressure, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot number 11232311

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

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

Timeline

Recall initiated: 2018-10-16
Terminated: 2021-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.