FDA Medical Device Recalls (openFDA)
Organ Recovery Systems, Inc.: SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
- Recall number
- Z-1111-2017
- 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
- Status
- Terminated
- Initiated
- 2016-12-14
- Posted
- not on file
- Terminated
- 2019-08-14
- Reason
- Organ preservation fluid recalled due to potential for bacterial contamination.
- 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
- 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K091656"]
- PMA numbers
- not on file
- Product code
- KDL
- Firm FEI
- 3004068499
- Firm city
- Itasca
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28