Recall Z-1111-2017— Organ Recovery Systems, Inc.

Name: FDA recall Z-1111-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-14

Class II · Terminated

Class II FDA medical device recall by Organ Recovery Systems, Inc., initiated 2016-12-14, terminated 2019-08-14. It names one FDA 510(k) clearance: K091656. Product: SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143. Reason: Organ preservation fluid recalled due to potential for bacterial contamination..

Recalling firm: Organ Recovery Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-14
Terminated: 2019-08-14
Firm location: Itasca, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc.·cleared 2010-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

Reason for recall

Organ preservation fluid recalled due to potential for bacterial contamination.

Data sourced from openFDA. This site is unofficial and independent of the FDA.