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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm June 08, 2001
Date Posted July 01, 2003
Recall Status1 Terminated 3 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/
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 2
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.