Recall Z-0024-2011
Terumo Cardiovascular Systems Corporation · initiated October 15, 2010
Product
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Codes / lots: all lots of cables distributed prior to 1/4/2008.
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: Other
Action taken
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.
Details
- Recall number
- Z-0024-2011
- Initiated
- October 15, 2010
- Posted by FDA
- October 8, 2010
- Terminated
- June 29, 2012
- Product code
- KRL – Detector, Bubble, Cardiopulmonary Bypass
- Quantity
- 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…
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI