Events

Recall of Liquid Bicarbinate

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
    49580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0439-2009
  • Event Date Posted
    2009-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73836
  • 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
    dialysate concentrate for hemodialysis (liquid ) - Product Code KPO
  • Reason
    Microbial growth was observed in the retain samples of 4 lots of liquid bicarbonate after products had been distributed.
  • Action
    Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08. A follow-up response form was faxed to consignees starting 10/01/08. Consignees asked to return product for a credit. For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.

Device

Liquid Bicarbinate
  • Model / Serial
    Lot #10442, 10461 and 10462.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
  • Product Description
    SteriLyte¿¿ Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure¿¿ Liquid Acid Concentrate or DC-Series Dri-Sate¿¿ Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
  • 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