Events

Recall of Belzer UW Cold Storage Solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Preservation Solutions 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
    56913
  • Event Risk Class
    Class 3
  • Event Number
    Z-0427-2011
  • Event Date Posted
    2010-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94913
  • 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
    System, perfusion, kidney - Product Code KDN
  • Reason
    Mislabeled volume - 2 liter bags of belzer uw cold storage solution were labeled as 1 liter.
  • Action
    Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..

Device

Belzer UW Cold Storage Solution
  • Model / Serial
    Batch # Bt017170, Lot# BC071710
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - in US to the states of CA, MO, and PA.
  • Product Description
    Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
  • Manufacturer
    Preservation Solutions Inc

Manufacturer

Preservation Solutions Inc
  • Manufacturer Address
    Preservation Solutions Inc, 980 Proctor Dr., P.O. Box 937, Elkhorn WI 53121-0937
  • Source
    USFDA