Recall Z-0295-2009 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195215. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 ba
| Date | Nov 7, 2008 (initiated May 23, 2008) |
| Status | Terminated |
| Reason | The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition. |
| Root cause | Nonconforming Material/Component |
| Action | U.S. consignees were notified by (Urgent Medical Device Removal) letter dated 5/23/08 via FedEx and international affiliates were notified via e-mail on 5/27/08. Consignees were advised of the problem, and to continue using the affected sensors until replacements are available in late 2008. For questions or additional information, contact the Terumo CVS Customer Service at 1-800-521-2818. |
| Quantity | 574 |
| Distribution | Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirat |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871131 | SARNS 9000 HEART-LUNG CONSOLE 3M Health Care, Sarns, May 21, 1987 |