Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0951-03

ESPRIT VENTILATOR, Model V1000

Respironics, Inc. / initiated 2001-06-08 / Terminated / root cause: design

Respironics California Inc began a recall of ESPRIT VENTILATOR, Model V1000 on . The reason FDA records is "Material hardness on original design check valve may cause premature failure". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0951-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
ESPRIT VENTILATOR, Model V1000
Product code
CPK
Reason for recall
Material hardness on original design check valve may cause premature failure.
Root cause tag
design
FDA root cause
Other
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.
Product codes and lots
All Codes.