Recall Z-1111-2017 ยท KDL Set, Perfusion, Kidney, Disposable
Organ Recovery Systems, Inc.
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
| Date | Dec 14, 2016 |
| Status | Terminated |
| 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 messagin |
| Quantity | 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L Organ Recovery Systems, Inc., Mar 11, 2010 |