Recall Z-1129-04 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Smiths Medical ASD, Inc.
Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;
| Date | Jul 22, 2004 (initiated Jul 13, 2004) |
| Status | Terminated |
| Reason | Sterility of the device is compromised due to lack of package integrity |
| Root cause | Other |
| Action | Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874597 | THERMOVENT 600, 1200, T, 02 Portex, Inc., Jan 19, 1988 |