RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Indus
FDA device recall Z-0326-05 · posted 2004-12-17 · Terminated
Recall details
- Recalling firm
- Medical Industries America Inc
- Reason for recall
- Units could show an error code and stop functioning.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 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.
- Date initiated
- 2004-09-03
- Date posted
- 2004-12-17
- Date terminated
- 2005-08-18
- Location
- Adel, IA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REMREST (K002763) | Medical Industries America, Inc. | 2001-05-04 |