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Terminated

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

FDA Recall Z-1191-06 · Posted 2006-07-01

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-09-19
Date Terminated2006-07-11
Product Quantity232 units

Reason for Recall

Gas input pressures over 62 psi may cause CPAP pressure oscillation

Firm 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)

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040862GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEMCaradyne, Ltd. · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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