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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Perfusion Systems Ultrasonic Air Sensor

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  Class 2 Device Recall Terumo Perfusion Systems Ultrasonic Air Sensor see related information
Date Initiated by Firm September 19, 2007
Date Posted January 24, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0530-2008
Recall Event ID 37989
510(K)Number K022947  
Product Classification Cardiopulmonary By-Pass Bubble Detector - Product Code KRL
Product 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
Code Information Serial Numbers: 1988 through 4450, 4452 through 4457, 4459 through 4485, 4487 through 4500, 4502 through 4525, 4527 through 4545 and 4551.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 False Alarms: 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 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, Taiwan, Thailand, United Arab Emirates, Uruguay, Venezuela and Vietnam.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KRL and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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