Class 2 Device Recall SPS1, Static Preservation Solution (UW Solution)

• Date Initiated by Firm: December 14, 2016
• Create Date: January 27, 2017
• Recall Status: Terminated on August 14, 2019
• Recall Number: Z-1111-2017
• Recall Event ID: 75978
• 510(K)Number: K091656
• Product Classification: Set, perfusion, kidney, disposable - Product Code KDL
• Product: SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
• Code Information: 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
• Recalling Firm/ Manufacturer: Organ Recovery Systems, Inc.; 1 Pierce Pl Ste 475; Itasca IL 60143-1253
• For Additional Information Contact: Matthew J. Copithorne ; 847-824-2421
• Manufacturer Reason for Recall: Organ preservation fluid recalled due to potential for bacterial contamination.
• FDA Determined Cause: Material/Component 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.
• Quantity in Commerce: 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDL and Original Applicant = ORGAN RECOVERY SYSTEMS, INC.