Recalls / —
—#175979
Product
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. 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
- 510(k) numbers
- K810637
- Affected lot / code info
- Lot number 11226919
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 #175979. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.