Recall Z-0530-2008 ยท KRL Detector, Bubble, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
| Date | Jan 24, 2008 (initiated Sep 19, 2007) |
| Status | Terminated |
| Reason | False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset. |
| Root cause | Process control |
| Action | Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available. |
| Quantity | 2,419 |
| Distribution | Worldwide: USA, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Equador, Germany, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Tai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022947 | ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH Terumo Cardiovascular Systems Corp., Mar 20, 2003 |