RecallDepth

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

Company
Respironics, Inc.
Recall Initiated
September 19, 2005
Posted
July 1, 2006
Terminated
July 11, 2006
Recall Number
Z-1191-06
Quantity
232 units
Firm Location
Murrysville, PA

Reason for Recall

Gas input pressures over 62 psi may cause CPAP pressure oscillation

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

Lot / Code Info

Serial numbers 5310050616-01, 5310050616-02, 5310050621-01

Root Cause

Other

Action Taken

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)

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