Z-1191-06

NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310

Name: Z-1191-06 NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
Creator: Respironics, Inc.
Published: 2005-09-19
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2005-09-19 / Terminated

FDA source

Respironics, Inc. began a recall of NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 on 2005-09-19. The reason FDA records is "Gas input pressures over 62 psi may cause CPAP pressure oscillation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1191-06
Status: Terminated
Initiated: 2005-09-19
Posted: 2006-07-01
Terminated: 2006-07-11
Recalling firm: Respironics, Inc.
Product: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Gas input pressures over 62 psi may cause CPAP pressure oscillation
FDA root cause: Other
Action: The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)
Quantity in commerce: 232 units
Distribution: World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium and Canada
Product codes and lots: Serial numbers 5310050616-01, 5310050616-02, 5310050621-01

Product code CBK

K040862Class IIGuardian Neonate Cpap/humidification SystemCaradyne, Ltd. / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)