Class 1 Device Recall

• Date Initiated by Firm: June 08, 2001
• Date Posted: July 01, 2003
• Recall Status: Terminated on May 11, 2004
• Recall Number: Z-0951-03
• Recall Event ID: 26432
• 510(K)Number: K981072
• Product Classification: unknown device name - Product Code CPK
• Product: ESPRIT VENTILATOR, Model V1000
• Code Information: All Codes.
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009
• For Additional Information Contact: Ramon Augusto Paz; 305-259-8880 Ext. 107
• Manufacturer Reason for Recall: Material hardness on original design check valve may cause premature failure.
• FDA Determined Cause: Other
• Action: Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
• Quantity in Commerce: 749
• Distribution: Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina.

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 = CPK and Original Applicant = RESPIRONICS, INC.