FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
- Recall number
- Z-1517-06
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
- Status
- Terminated
- Initiated
- 2006-06-23
- Posted
- 2006-09-29
- Terminated
- 2012-03-22
- 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
- Lot, serial or model codes
- Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP, 6O8AP6O8AD
- 510(k) numbers
- ["K020967"]
- PMA numbers
- not on file
- Product code
- CBZ
- Firm FEI
- 3013556777
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28