Events

Recall of Device Recall Belzer UW & Waters IGL 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
    79378
  • Event Risk Class
    Class 2
  • Event Number
    Z-1387-2018
  • Event Initiated Date
    2018-02-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162159
  • 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
    Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.
  • Action
    An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form.

Device

Device Recall Belzer UW & Waters IGL Cold Storage Solution
  • Model / Serial
    UDI 00810805000163, and UDI 00810805000071.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Europe.
  • Product Description
    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. || Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
  • Manufacturer
    Preservation Solutions, Inc.

Manufacturer

Preservation Solutions, Inc.
  • Manufacturer Address
    Preservation Solutions, Inc., 1099 Proctor Dr, Elkhorn WI 53121-2027
  • Source
    USFDA