FDAFDA · Food and drugs·Recall number Z-1111-2017
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Published February 8, 2017 · Recall initiated: December 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Organ preservation fluid recalled due to potential for bacterial contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Organ Recovery Systems, Inc.
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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