Recall Z-1517-06 ยท CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Terumo Cardiovascular Systems Corp
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
| Date | Sep 29, 2006 (initiated Jun 23, 2006) |
| Status | Terminated |
| Reason | Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance. |
| 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 | 175 |
| Distribution | Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM Terumo Cardiovascular Systems Corp., Jun 20, 2002 |