Events

Recall of Device Recall DriSate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rockwell Medical Technologies, 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
    46267
  • Event Risk Class
    Class 2
  • Event Number
    Z-0875-2008
  • Event Initiated Date
    2007-12-03
  • Event Date Posted
    2008-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67094
  • 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
    Liquid Acid Concentrate. - Product Code KPO
  • Reason
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Action
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.

Device

Device Recall DriSate
  • Model / Serial
    Lot #2530-1020052.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
  • Product Description
    Dri-Sate¿ Glacial Acidic Acid (liquid component of Dri-Sate¿ Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
  • Manufacturer
    Rockwell Medical Technologies, Inc

Manufacturer

Rockwell Medical Technologies, Inc
  • Manufacturer Address
    Rockwell Medical Technologies, Inc, 4051 Freeport Pkwy Ste 100, Grapevine TX 76099
  • Manufacturer Parent Company (2017)
    Rockwell Medical Inc.
  • Source
    USFDA