Recall Z-0311-2009 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir.
| Date | Dec 10, 2008 (initiated Jan 13, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.