Events

Recall of TissueTek PARAFORM PROC/EMB/MEDIUM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sakura Finetek USA 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
    68081
  • Event Risk Class
    Class 2
  • Event Number
    Z-1748-2014
  • Event Initiated Date
    2014-04-16
  • Event Date Posted
    2014-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126912
  • 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
    Formulations, paraffin, all - Product Code KEO
  • Reason
    This lot has variations in melting temperature.
  • Action
    Customer notifications sent via e-mail letter. The letter titled "PRODUCT RECALL" dated 04/17/2014 informed customers (of Lot 263922), informed customers of the recall by providing the following information: product name, code, lot number, reason for recall, requested actions, contact information and an "FIELD CORRECTION EFFECTIVENESS CHECK" form.

Device

TissueTek PARAFORM PROC/EMB/MEDIUM
  • Model / Serial
    Product Code: 7052. Lot Number: 263922.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. || for diagnostic chemistry use. || Sakura Finetek USA, Inc.
  • Manufacturer
    Sakura Finetek USA Inc

Manufacturer

Sakura Finetek USA Inc
  • Manufacturer Address
    Sakura Finetek USA Inc, 1750 W 214th St, Torrance CA 90501-2857
  • Manufacturer Parent Company (2017)
    Sakura Global Holding Co. Ltd.
  • Source
    USFDA