Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0722-04

Esprit Ventilator

Respironics, Inc. / initiated 2003-07-14 / Terminated / root cause: manufacturing process

Respironics California Inc began a recall of Esprit Ventilator on . The reason FDA records is "Valves may stick in the closed position due to manufacturing error". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0722-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
Esprit Ventilator.
Product code
CBK Ventilator, Continuous, Facility Use
Reason for recall
Valves may stick in the closed position due to manufacturing error.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
Quantity in commerce
20
Distribution
OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
Product codes and lots
Serial numbers: VS300430, VS3004361, VS3004335, VS3004301, VS3004327, VS3004353, VS3004377, VS3004366, VS3004328, VS3004337, VS3004357, VS3004385, VS3004369, VS3004295, VS3004310, VS3004292, VS3004305, VS3004381, VS3004296, VS3004299.