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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Ultrasonic Air Sensor

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 Class 2 Recall
Sarns Ultrasonic Air Sensor
see related information
Date Posted October 08, 2010
Recall Status1 Terminated on June 29, 2012
Recall Number Z-0024-2011
Recall Event ID 56645
Premarket Notification
510(K) Number
K940651 
Product Classification Detector, Bubble, Cardiopulmonary Bypass - Product Code KRL
Product Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Code Information all lots of cables distributed prior to 1/4/2008.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. .
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm sent URGENT MEDICAL DEVICE CORRECTION notices dated September 17, 2010. The notices told consignees that a Terumo representative would visit, inspect the cables and replace the recalled cables. if the customer has a service contract, the visits would occur at the next scheduled preventative maintenance visit. Customers without a service contract will be contacted by Terumo representative to schedule an appointment. Customers can contact Terumo Customer Service at 800-521-2818.
Quantity in Commerce 5,000 estimated
Distribution Worldwide Distribution: USA states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Belgium, Canada, Columbia, Chile, Costa Rica, Germany, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Korea, Mexico, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Taiwan, UAE and Vietnam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KRL and Original Applicant = 3M HEALTH CARE, SARNS
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