The Recall Desk
HighFDA (Devices)·Z-1111-2017·Announced 2017-02-08

Organ Preservation Solution Recalled for Potential Bacterial Contamination

Organ Recovery Systems is recalling SPS-1 Static Preservation Solution bags due to potential bacterial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (bacterial contamination) in a medical device without reported illness, fitting the 'High' severity criteria.

Plain-English summary

Organ Recovery Systems, Inc. is recalling SPS-1, Static Preservation Solution, in 1-liter and 2-liter sterile bags. The recall involves 4,806 bags distributed nationwide.

The recall was initiated due to the potential for bacterial contamination in the organ preservation fluid. Specific lot numbers and expiration dates are listed in the official recall notice.

Healthcare facilities and consumers who have these products should stop using them and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Manufacturer
Organ Recovery Systems, Inc.
Category
Medical Device — Organ Preservation
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Organ Recovery Systems, Inc.

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Same hazard · bacterial contamination

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