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

FDA device recall Z-0024-2011 · posted 2010-10-08 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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 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.

Root cause

Other

Status

Terminated

Product code

KRL

Quantity affected

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

Date initiated

2010-10-15

Date posted

2010-10-08

Date terminated

2012-06-29

Location

Ann Arbor, MI