| Class 2 Device Recall Terumo Perfusion Systems Ultrasonic Air Sensor | |
Date Initiated by Firm | September 19, 2007 |
Date Posted | January 24, 2008 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number | Z-0532-2008 |
Recall Event ID |
37989 |
510(K)Number | K022947 |
Product Classification |
Cardiopulmonary By-Pass Bubble Detector - Product Code KRL
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Product | Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103 |
Code Information |
Serial Numbers: 1091 through 1307. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
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For Additional Information Contact | 800-521-2818 |
Manufacturer 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 2 | 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 in Commerce | 175 |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KRL
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