Recall Z-0326-05 ยท BZD Ventilator, Non-Continuous (Respirator)
Medical Industries America Inc
RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
| Date | Dec 17, 2004 (initiated Sep 3, 2004) |
| Status | Terminated |
| Reason | Units could show an error code and stop functioning. |
| Root cause | Other |
| Action | The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users. |
| Quantity | 74 units |
| Distribution | Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002763 | REMREST Medical Industries America, Inc., May 4, 2001 |