Z-1111-2017Class II

SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place...

Name: Z-1111-2017 SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place...
Creator: Organ Recovery Systems, Inc.
Published: 2016-12-14
License: https://open.fda.gov/license/

Organ Recovery Systems, Inc. / initiated 2016-12-14 / Terminated / root cause: manufacturing process

FDA source

Organ Recovery Systems, Inc. began a recall of SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 on 2016-12-14. FDA classified it as Class II and gives the reason as "Organ preservation fluid recalled due to potential for bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1111-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-14
Posted: 2017-01-27
Terminated: 2019-08-14
Recalling firm: Organ Recovery Systems, Inc.
Product: SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Product code: KDL Set, Perfusion, Kidney, Disposable
Reason for recall: Organ preservation fluid recalled due to potential for bacterial contamination.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1111-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1111-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-27

Product code KDL

K091656Class IISps-1Tm Static Preservation Solution, Models Sps-1-500 Ml, Sps 1-1L, Sps-1-2LOrgan Recovery Systems, Inc. / cleared 2010-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)