Terumo Cardiovascular Systems Corp TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD
Products Sold
Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD
Terumo Cardiovascular Systems Corp is recalling TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205 due to Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026