NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
FDA device recall Z-0717-06 · posted 2006-04-07 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
- Action taken
- Respironics contacted customers via tracked letter informing them to discontinue use of their NeoPAP system. Distributors were contacted via telephone and e-mail instructing them to contact their customers and instruct them to discontinue use of the NeoPAP system. The recalling firm issued a Customer Advisory Notice (CAN) dated 1/5/06 to all customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 83 effected units were identified
- Distribution
- The product was shipped to medical facilities in GA, IA, MA, MN, NJ, OK, PA, TX, and WI. The product was also shipped to Sweden, South Africia, Egypt, Greece, and Saudi Arbia.
- Date initiated
- 2005-12-27
- Date posted
- 2006-04-07
- Date terminated
- 2007-03-22
- 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 |