Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion Sy
FDA device recall Z-0311-2009 · posted 2008-12-10 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.
- Action taken
- Consignees were notified via recall letter (Urgent Medical Device Removal letter) dated 2/13/08 and requested to report stocks on hand so that replacements could be sent.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 31,980 pads (25,620 to U.S. and 6,360 international)
- Distribution
- Worldwide Distribution including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Japan, Saudi Arabia, Singapore and Yemen.
- Date initiated
- 2008-01-13
- Date posted
- 2008-12-10
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
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