Class 2 Device Recall NeoPAP

• Date Initiated by Firm: September 19, 2005
• Date Posted: July 01, 2006
• Recall Status: Terminated on July 11, 2006
• Recall Number: Z-1191-06
• Recall Event ID: 35608
• 510(K)Number: K040862
• Product Classification: Ventilator, Continuous - Product Code CBK
• Product: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
• Code Information: Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
• Recalling Firm/ Manufacturer: Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• For Additional Information Contact: James Vetricek; 724-387-4559
• Manufacturer Reason for Recall: Gas input pressures over 62 psi may cause CPAP pressure oscillation
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK