Events

Recall of Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell Reservoir

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

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
    60475
  • Event Risk Class
    Class 3
  • Event Number
    Z-0842-2012
  • Event Initiated Date
    2010-06-28
  • Event Date Posted
    2012-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105511
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Reason
    Complaints were received of expired x-coated capiox sx18 hollow fiber oxygenators.
  • Action
    All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed "Urgent Medical Device Removal " letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.

Device

Device Recall CAPIOX SX18 Hollow Fiber Oxygenator w/Detachble Hardshell Reservoir
  • Model / Serial
    Product code 3CXSX18RX, Lot # HF22
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of: WI, MO,and KY.
  • Product Description
    Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 ¿. 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.
  • Manufacturer
    Terumo Cardiovascular Corporation

Manufacturer

Terumo Cardiovascular Corporation
  • Manufacturer Address
    Terumo Cardiovascular Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA