—#48165

Product

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205

FDA product code: CBZ — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K020967
Affected lot / code info: Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD

Why it was recalled

Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.

Root cause (FDA determination)

Other

Action the firm took

The affected lots were identified as those lots manufactured in the first quarter of the calendar year 2006. The distribution of affected lots was traced. A letter and a customer response form were developed and each of the five US customers were sent the recall letter via Federal Express. The two international affiliates were contacted and instructed to contact their customers in a manner similar to one used by Terumo CVS in the US. Reconciliation will involve confirmation that the response form for each of the customers and affiliates has been completed and returned to Terumo CVS.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 1311 Valencia Ave, Tustin, California 92780-6447

Distribution

Distribution pattern: Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait

Timeline

Recall initiated: 2006-06-23
Posted by FDA: 2006-09-29
Terminated: 2012-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.