Events

Recall of Device Recall Lithium Heparin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Celsus Laboratories 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
    48084
  • Event Risk Class
    Class 2
  • Event Number
    Z-1917-2008
  • Event Initiated Date
    2008-03-31
  • Event Date Posted
    2008-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70821
  • 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
    Lithium Heparin - Product Code JKA
  • Reason
    Contamination: the firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.
  • Action
    Celsus notified their customers by e-mail on April 24, 2008, explaining that oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. Celsus recommended the device manufacturers quarantine material from the specified lots.

Device

Device Recall Lithium Heparin
  • Model / Serial
    Lot# HL-31707, HL-31807, HL-32708, HL-32808 & HL-32908
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. The Lithium Heparin was sold to companies in USA (Nebraska, New Jersey, Ohio), Puerto Rico, Austria, and Denmark.
  • Product Description
    Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
  • Manufacturer
    Celsus Laboratories Inc

Manufacturer

Celsus Laboratories Inc
  • Manufacturer Address
    Celsus Laboratories Inc, 12150 Best Pl, Cincinnati OH 45241-1569
  • Manufacturer Parent Company (2017)
    Celsus Laboratories Inc
  • Source
    USFDA