NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
FDA Recall Z-0717-06 · Posted 2006-04-07
Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-12-27
Date Terminated2007-03-22
Product Quantity83 effected units were identified
Reason for Recall
Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.