TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
FDA device recall Z-1517-06 · posted 2006-09-29 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBZ
- Quantity affected
- 175
- Distribution
- Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
- Date initiated
- 2006-06-23
- Date posted
- 2006-09-29
- Date terminated
- 2012-03-22
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967) | Terumo Cardiovascular Systems Corp. | 2002-06-20 |