Class 3 Device Recall

• Date Initiated by Firm: February 20, 2002
• Date Posted: July 28, 2004
• Recall Status: Terminated on December 02, 2004
• Recall Number: Z-1230-04
• Recall Event ID: 29385
• 510(K)Number: k981072 k001208 k023350 k034040
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Esprit Ventilator
• Code Information: Too numerous to include.
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009-1517
• For Additional Information Contact: Anil Bhalani; 760-918-7300
• Manufacturer Reason for Recall: Flow sensors would exhibit drift.
• FDA Determined Cause: Other
• Action: Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
• Quantity in Commerce: 907
• Distribution: Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam
• 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 and Original Applicant = RESPIRONICS CALIFORNIA, INC.; 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.