Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1230-04

Esprit Ventilator

Respironics, Inc. / initiated 2002-02-20 / Terminated

Respironics California Inc began a recall of Esprit Ventilator on . The reason FDA records is "Flow sensors would exhibit drift". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1230-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
Esprit Ventilator
Product code
CBK Ventilator, Continuous, Facility Use
Reason for recall
Flow sensors would exhibit drift.
FDA root cause
Other
Action
Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
Quantity in commerce
907
Distribution
Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam
Product codes and lots
Too numerous to include.