Z-1517-06

Terumo Khuri Myocardial Ph Monitoring System, Catalog Number 7205

Name: Z-1517-06 Terumo Khuri Myocardial Ph Monitoring System, Catalog Number 7205
Creator: Terumo Cardiovascular Systems Corp
Published: 2006-06-23
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2006-06-23 / Terminated / root cause: sterility

FDA source

Terumo Cardiovascular Systems Corp began a recall of TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205 on 2006-06-23. The reason FDA records is "Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1517-06
Status: Terminated
Initiated: 2006-06-23
Posted: 2006-09-29
Terminated: 2012-03-22
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Khuri Myocardial Ph Monitoring System, Catalog Number 7205
Product code: CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Reason for recall: Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Quantity in commerce: 175
Distribution: Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
Product codes and lots: Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD

Product code CBZ

K020967Class IITerumo Khuri Myocardial Ph Monitoring SystemTerumo Cardiovascular Systems Corp. / cleared 2002-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)