Events

Recall of Device Recall Century Console Base

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Salyer Prn Biomedical.

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
    64383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0902-2013
  • Event Initiated Date
    2013-01-31
  • Event Date Posted
    2013-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115964
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    Concerns that the addition of the ups battery backup to the century console base shelf did not comply with the fda premarket notification regulations.
  • Action
    An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232.

Device

Device Recall Century Console Base
  • Model / Serial
    Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MA,CA, and WI.
  • Product Description
    Century Console Base, Model #043625051b. || Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
  • Manufacturer
    Salyer Prn Biomedical

Manufacturer

Salyer Prn Biomedical
  • Manufacturer Address
    Salyer Prn Biomedical, 1833 W Main St Ste 116, Mesa AZ 85201-6924
  • Source
    USFDA