CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report
SPS-1, Static Preservation Solution [1 or bags], Sterile recalled
Organ Recovery Systems is recalling SPS-1, Static Preservation Solution [1 or bags], Sterile, distributed nationwide in the US. The recall was initiated on 14 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1111-2017
- FDA event ID
- 75978
- Recalling firm
- Organ Recovery Systems, Itasca, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2016
- FDA classified
- 27 Jan 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Dec 2016 | Recall initiated by company | |
| 27 Jan 2017 | Classified by FDA | +44 days |
| 8 Feb 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Organ preservation fluid recalled due to potential for bacterial contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Where it was distributed
Nationwide
Questions about this recall
Is SPS-1, Static Preservation Solution [1 or bags], Sterile recalled?
Yes. Organ Recovery Systems recalled SPS-1, Static Preservation Solution [1 or bags], Sterile on 14 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1111-2017.
Why was it recalled?
Organ preservation fluid recalled due to potential for bacterial contamination.
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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