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Terminated

ESPRIT VENTILATOR, Model V1000

FDA Recall Z-0951-03 · Posted 2003-07-01

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCPK
Date Initiated2001-06-08
Date Terminated2004-05-11
Product Quantity749

Reason for Recall

Material hardness on original design check valve may cause premature failure.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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