Recall Z-0293-2020 ยท DRS Transducer, Blood-Pressure, Extravascular
Argon Medical Devices, Inc
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devi
| 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
| K771701 | VESSEL-CLUDE Med General, Dec 13, 1977 |