Events

Recall of Device Recall SPS1, Static Preservation Solution (UW Solution)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Organ Recovery Systems, 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
    75978
  • Event Risk Class
    Class 2
  • Event Number
    Z-1111-2017
  • Event Initiated Date
    2016-12-14
  • 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=151877
  • 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
    Set, perfusion, kidney, disposable - Product Code KDL
  • Reason
    Organ preservation fluid recalled due to potential for bacterial contamination.
  • Action
    Firm initiated a voluntary removal of Lot PBR-0060-392 on December 14, 2016. and Lot PBR-0074-330 December 16, 2016. Notification occurred via e-mail to each recipient of the lots. On December 18, 2016, the firm provided subsequent posting notice and FAQs on company website. Follow up telephone conversations were performed post e-mail notifications. Firm worked with FDA to develop and coordinate a unified message that would be noticed on the websites of FDA, UNOS, and CDC. Firm also independently contacted the Association of Organ Procurement Organizations and UNOS to assist with messaging for their constituents. In the recall notification emails, customers were instructed to return affected product to Organ Recovery Systems. All affected product will be destroyed after completion of the firm's internal investigation. Upon learning of the additional lots of potentially contaminated product (PBR-¿0074-¿337 and PBR-¿0060-¿386), on 1/13/2017 ORS notified their customers via email and phone and updated the posting on their website. The instructions were only to quarantine the product, however. On January 23, 2017, firm began instructing their customers (via email) to return the additional affected lots to ORS. An update to their website was posted January 24, 2017. instructing affected customers to return the lots of product. For further questions regarding this recall, please call (847) 824-2421.

Device

Device Recall SPS1, Static Preservation Solution (UW Solution)
  • Model / Serial
    Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ;   Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018  Batch / Lot Number: PBR-0074-337  Batch / Lot Number: PBR-0060-386
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
  • Manufacturer
    Organ Recovery Systems, Inc.

Manufacturer

Organ Recovery Systems, Inc.
  • Manufacturer Address
    Organ Recovery Systems, Inc., 1 Pierce Pl Ste 475, Itasca IL 60143-1253
  • Manufacturer Parent Company (2017)
    Organ Recovery Systems Inc.
  • Source
    USFDA