Recall Z-0717-06 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
| Date | Apr 7, 2006 (initiated Dec 27, 2005) |
| Status | Terminated |
| Reason | Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM Caradyne, Ltd., Jun 30, 2004 |