Events

Recall of Terumo APS 1

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
    36396
  • Event Risk Class
    Class 2
  • Event Number
    Z-0336-2007
  • Event Initiated Date
    2004-10-12
  • Event Date Posted
    2006-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48589
  • 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
    Perfusion System - Product Code DTQ
  • Reason
    Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'x' being displayed on the monitor screen.
  • Action
    U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Device

Terumo APS 1
  • Model / Serial
    Serial numbers 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105 through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241, 00245 through 00250, 00300 through 00327 and 00330.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • Product Description
    Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA