Home / Recalls / Organ Recovery Systems, Inc. / Z-1111-2017

Z-1111-2017 Class II Terminated

Recalled by Organ Recovery Systems, Inc. — Itasca, IL

Recall Details

Product Type: Devices
Report Date: February 8, 2017
Initiation Date: December 14, 2016
Termination Date: August 14, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)

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.

Distribution Pattern

Nationwide

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