Recall Z-1596-2015 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Arc Medical Inc
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
| Date | May 9, 2015 (initiated Feb 19, 2015) |
| Status | Terminated |
| Reason | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. |
| Root cause | Process control |
| Action | Consignees were contacted by telephone on 02/19/2015. |
| Quantity | 1810 units |
| Distribution | Distributed in CA and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903054 | HME-10 (TM) Pharma Systems, Inc., Oct 31, 1990 |