Recall Z-0531-2008
Terumo Cardiovascular Systems Corp · initiated September 19, 2007
Product
Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103
Codes / lots: Serial Numbers: 1106 through 1370 and 1376.
Reason for recall
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0531-2008
- Initiated
- September 19, 2007
- Posted by FDA
- January 24, 2008
- Terminated
- July 7, 2009
- Product code
- KRL – Detector, Bubble, Cardiopulmonary Bypass
- Quantity
- 232
- 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, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.
- Recalling firm
- Terumo Cardiovascular Systems Corp, Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0530-2008 | Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo…False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus… | 09/19/2007Terminated |
| Z-0532-2008 | Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo…False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus… | 09/19/2007Terminated |