Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36193
  • Event Risk Class
    Class 2
  • Event Number
    Z-1517-06
  • Event Initiated Date
    2006-06-23
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48165
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ph monitor - Product Code CBZ
  • Reason
    Lack of assurance of sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.
  • 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.

Device

Device Recall Terumo Analyzer, Ion, HydrogenIon (pH), BloodPhase, Indwelling
  • Model / Serial
    Lots Affected: 2006-O6AD, 2006-O8AD, 2006-O8AP,  6O8AP6O8AD
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in CA, IL, MA, MD, NC, & OK; Internationally in Belgium & Kuwait
  • Product Description
    TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 1311 Valencia Ave, Tustin CA 92780-6447
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA