Reported Feb 8, 2017 · Terminated

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

Organ Recovery Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Organ Recovery Systems, Inc. · 1 Pierce Pl Ste 475 · Itasca, IL · 60143-1253

Is this the product you have?

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

6 of 6 products

Products covered by this recall
#Product as published
1Lot Number: PBR-0060-392
2Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ; Batch /
3Lot Number: PBR-0074-330
4Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018 Batch /
5Lot Number: PBR-0074-337 Batch /
6Lot Number: PBR-0060-386
Amount recalled
4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)

Where it was sold

  • Nationwide

Why it was recalled

Organ preservation fluid recalled due to potential for bacterial contamination.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 14, 2019 · Data as of Sep 19, 6:01 PM UTC

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