Class 2 Device Recall

• Date Initiated by Firm: July 14, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 17, 2004
• Recall Number: Z-0722-04
• Recall Event ID: 28263
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Esprit Ventilator.
• Code Information: Serial numbers: VS300430, VS3004361, VS3004335, VS3004301, VS3004327, VS3004353, VS3004377, VS3004366, VS3004328, VS3004337, VS3004357, VS3004385, VS3004369, VS3004295, VS3004310, VS3004292, VS3004305, VS3004381, VS3004296, VS3004299.
• FEI Number: 2518422
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009-1517
• For Additional Information Contact: Anil Bhalani; 760-918-7458
• Manufacturer Reason for Recall: Valves may stick in the closed position due to manufacturing error.
• FDA Determined Cause: Other
• Action: Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
• Quantity in Commerce: 20
• Distribution: OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
• 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.