Events

Recall of Device Recall Martel Printer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point of Care 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
    53674
  • Event Risk Class
    Class 2
  • Event Number
    Z-1133-2010
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2010-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86307
  • 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
    Printer - Product Code CGA
  • Reason
    Some martel printers used with the i-stat 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
  • Action
    An "Urgent Recall Notice" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to please follow the instructions on the enclosed customer reply cared. If in doubt regarding identification of the affected Martel printers, contact Abbott Point of Care Technical Support. If you have any questions regarding this information or if removing the affected Martel printers from use will negatively impact patient care, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.

Device

Device Recall Martel Printer
  • Model / Serial
    List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    Martel Printer || The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • Manufacturer Address
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA