Events

Recall of Device Recall Clark Biocompatible Hemoperfusion

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clark Research and Development 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
    37289
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-2007
  • Event Initiated Date
    2007-01-19
  • Event Date Posted
    2007-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50287
  • 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
    Hemoperfusion filter - Product Code FLD
  • Reason
    Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions.
  • Action
    The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.

Device

Device Recall Clark Biocompatible Hemoperfusion
  • Model / Serial
    Lot numbers 564 though 577
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
  • Manufacturer
    Clark Research and Development Inc

Manufacturer

Clark Research and Development Inc
  • Manufacturer Address
    Clark Research and Development Inc, Number 13 Park Lane, Folsom LA 70437
  • Source
    USFDA