FDA Medical Device Recalls (openFDA)
Respironics, Inc.: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
- Recall number
- Z-0717-06
- Recalling firm
- Respironics, Inc.
- Product
- NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous)
- Status
- Terminated
- Initiated
- 2005-12-27
- Posted
- 2006-04-07
- Terminated
- 2007-03-22
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K040862"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28