TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
This recall has been terminated (originally issued September 29, 2006).
- Recall Initiated
- June 23, 2006
- Posted
- September 29, 2006
- Terminated
- March 22, 2012
- Recall Number
- Z-1517-06
- Quantity
- 175
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
Distribution
Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
Lot / Code Info
Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD
Root Cause
Other
Action Taken
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.