NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
FDA device recall Z-1191-06 · posted 2006-07-01 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Gas input pressures over 62 psi may cause CPAP pressure oscillation
- Action taken
- The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 232 units
- Distribution
- World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France,
- Date initiated
- 2005-09-19
- Date posted
- 2006-07-01
- Date terminated
- 2006-07-11
- Location
- Murrysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM (K040862) | Caradyne, Ltd. | 2004-06-30 |