NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
This recall has been terminated (originally issued April 7, 2006).
- Company
- Respironics, Inc.
- Recall Initiated
- December 27, 2005
- Posted
- April 7, 2006
- Terminated
- March 22, 2007
- Recall Number
- Z-0717-06
- Quantity
- 83 effected units were identified
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
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.
Lot / Code Info
Lot codes: 3124050609-01, 3124050609-02, 3124050609-03, 3124050803-01, 3124050803-02, 3124050803-03, 3124050803-04, 3124050803-05, 3124050623-01, 5313050323-01, 5313050620-01, 5306050624-01, 5306050623-01, 5306050323-01, 4568050622-01, 4568050415-01, 3195050217-06, 3195050511-01, 3195050426-12, 3195050511-02, 3195050511-03, 3195050511-05, 3195050511-07, 3195050511-08, 3195050511-10, 3195050520-07, 3195050412-05, 3195050418-02, 3195050418-03, 3195050418-06, 3195050418-07, 3195050418-09, 3195050418-13, 3195050418-14, 3195050418-15, 3195050426-01, 3195050426-02, 3195050426-03, 3195050426-04, 3195050426-05, 3195050426-11, 3195050426-13, 3195050426-14, 3195050426-15, 3195050511-09, 3195050511-11, 3195050511-12, 3195050511-13, 3195050511-14, 3195050511-15, 3195050520-01, 3195050520-02, 3195050520-03, 3195050520-04, 3195050520-05, 3195050527-02, 3195050527-03, 3195050527-04, 3195050527-05, 3195050527-06, 3195050527-07, 3195050527-08, 3195050131-08, 3195050120-02, 3195050120-07, 3195050120-08, 3195050120-09, 3195050114-03, 3195050527-12, 3195050527-13, 3195050527-14, 3195050527-15, 3195050609-01, 3195050609-02, 3195050609-04, 3195050722-07, 3195050609-07, 3155050722-04, 3155050722-05, 3195050811-03, 3195050426-07, 3195050609-09, 3195050811-04
Root Cause
Other
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.