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Terminated

Esprit Ventilator.

FDA Recall Z-0722-04 · Posted 2004-07-20

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2003-07-14
Date Terminated2004-03-17
Product Quantity20

Reason for Recall

Valves may stick in the closed position due to manufacturing error.

Firm Action

Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.

Root Cause

Other

Distribution Pattern

OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.

Official Source

View FDA Recall →

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

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