Recall Z-0294-2020 ยท DRS Transducer, Blood-Pressure, Extravascular
Argon Medical Devices, Inc
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.
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | 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 | Equipment maintenance |
| 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. |
| Quantity | Total number in recall for all products in dist: 49,130 units |
| Distribution | Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.