Events

Recall of Device Recall TEG 5000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haemoscope Division of Haemonetics Corp.

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
    57809
  • Event Risk Class
    Class 2
  • Event Number
    Z-1738-2011
  • Event Initiated Date
    2011-01-28
  • Event Date Posted
    2011-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97481
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Reason
    Haemonetics has received a report of smoke from the unit with a power supply failure.
  • Action
    Haemoscope sent letters to all of their U.S. accounts on January 24, 2011, via certified mail. The letters listed guidelines regarding proper use of the TEG 5000 System Power Supply to eliminate any potential risks such as electrical shorting or power supply damage. The information, which was printed in the letter, will also be available in an updated TEG User Manual soon to be released. A Caution label with installation instructions was included with the letter, to be applied to the back of the TEG unit. The accounts were requested to complete the enclosed acknowledgement form and fax it back to Haemoscope at 847-588-0455. Any questions were directed to 1-800-438-2834.

Device

Device Recall TEG 5000
  • Model / Serial
    list 07-022 (TEG 5000), all serial numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA
  • Product Description
    TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 || a multipurpose system for in vitro coagulation studies
  • Manufacturer
    Haemoscope Division of Haemonetics Corp

Manufacturer

Haemoscope Division of Haemonetics Corp
  • Manufacturer Address
    Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
  • Manufacturer Parent Company (2017)
    Haemonetics Corporation
  • Source
    USFDA