Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Analyzer, Ion, HydrogenIon (pH), BloodPhase, Indwelling

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Terumo Analyzer, Ion, HydrogenIon (pH), BloodPhase, Indwellingsee related information
Date Initiated by FirmJune 23, 2006
Date PostedSeptember 29, 2006
Recall Status1 Terminated 3 on March 22, 2012
Recall NumberZ-1517-06
Recall Event ID 36193
510(K)NumberK020967 
Product Classification Ph monitor - Product Code CBZ
ProductTERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
Code Information Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP,  6O8AP6O8AD
FEI Number 3003523199
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
1311 Valencia Ave
Tustin CA 92780-6447
For Additional Information ContactMary McDermott
714-247-8025
Manufacturer Reason
for Recall		Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce175
DistributionNationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CBZ
-
-