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Terminated

TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205

FDA Recall Z-1517-06 · Posted 2006-09-29

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeCBZ
Date Initiated2006-06-23
Date Terminated2012-03-22
Product Quantity175

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020967TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEMTerumo Cardiovascular Systems Corp. · 2002-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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