Events

Recall of Device Recall SigmaAldrich Histopaque1119

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sigma-Aldrich Mfg LLC.

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
    53956
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-2010
  • Event Initiated Date
    2009-12-08
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86942
  • 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
    Histopaque-1119 - Product Code JCF
  • Reason
    Instructions for use (ifu) was revised to recommend sterile filtering of the product under certain circumstances.
  • Action
    The recalling firm issued an "Urgent Field Correction" notice dated December 7, 2009 via regular mail on December 8, 2009 which explains the reason for the field correction and instructs the user to review the enclosed, revised Instructions for Use (IFU) prior to further use of the product. The customer is requested to complete the acknowledgement information and return it to the recalling firm via FAX or e-mail. Direct questions to Sigma-Aldrich by calling 1-800-505-6275, extension 1232.

Device

Device Recall SigmaAldrich Histopaque1119
  • Model / Serial
    Lots 038K6030, 126K6002, and 079K6047.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa.
  • Product Description
    Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. || The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.
  • Manufacturer
    Sigma-Aldrich Mfg LLC

Manufacturer

Sigma-Aldrich Mfg LLC
  • Manufacturer Address
    Sigma-Aldrich Mfg LLC, 545 S Ewing Ave, Saint Louis MO 63103-2932
  • Manufacturer Parent Company (2017)
    Merck KGaA
  • Source
    USFDA