Events

Recall of Separation Technology ClearCRIT Capillary Tubes 1.1mm ID

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Drummond Scientific Co.

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
    49092
  • Event Risk Class
    Class 2
  • Event Number
    Z-0211-2009
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2008-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72737
  • 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
    Capillary Blood Collection Tube - Product Code GIO
  • Reason
    Presence of oscs contaminant.
  • Action
    The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.

Device

Separation Technology ClearCRIT Capillary Tubes 1.1mm ID
  • Model / Serial
    Lot numbers 0715, 1158, 1428, and 1898
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of FL and MA.
  • Product Description
    Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. || Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
  • Manufacturer
    Drummond Scientific Co

Manufacturer

Drummond Scientific Co
  • Manufacturer Address
    Drummond Scientific Co, 500 Parkway, Broomall PA 19008
  • Manufacturer Parent Company (2017)
    Drummond Scientific Co
  • Source
    USFDA