—#94171

Product

Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI

FDA product code: KRL — Detector, Bubble, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: all lots of cables distributed prior to 1/4/2008.

Why it was recalled

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. .

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-10-15
Posted by FDA: 2010-10-08
Terminated: 2012-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94171. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.