Medical Device Recall: Z-0024-2011

FDA Recalls dataset · Firm: Terumo Cardiovascular Systems Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-10-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0024-2011.

Recall Res Number
Z-0024-2011
Recalling Firm / Manufacturer
Terumo Cardiovascular Systems Corporation
FEI Number
1828100
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-10-15
Date Posted
2010-10-08
Date Terminated
2012-06-29
Product Code
KRL
Event Number
56645
Product Quantity
5,000 estimated
Product Description Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
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. .
Action Details 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.
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.
Code Information / Serial Numbers all lots of cables distributed prior to 1/4/2008.

Related Establishments / Registrations

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