Events

Recall of Device Recall Pump, blood, extraluminal

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Apheresis Technologies, Inc..

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
    62563
  • Event Risk Class
    Class 2
  • Event Number
    Z-2149-2012
  • Event Initiated Date
    2012-07-09
  • Event Date Posted
    2012-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111049
  • 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
    Pump, blood, extra-luminal - Product Code FIR
  • Reason
    On 07/09/2012, apheresis technologies, inc. initiated a recall on the plasma pump model pp-04a due to a complaint received regarding a rotor of the pp-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.
  • Action
    APHERESIS TECHNOLOGIES, INC. sent a letter dated July 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the device for repair. For questions customers should call 727-787-5616.

Device

Device Recall Pump, blood, extraluminal
  • Model / Serial
    D11003544 through D11003552 D11003556 through D11003558
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natonwide Distribution
  • Product Description
    Plasma Pump Model PP-04a || Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
  • Manufacturer
    Apheresis Technologies, Inc.

Manufacturer

Apheresis Technologies, Inc.