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Recall Observatory FDA recall evidence

Device product

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

Z-1111-2017

December 14, 2016

Class II

Product summary

Firm
Organ Recovery Systems, Inc.
Event
Event 75978
Status
Terminated
Classification
Class II
Quantity
4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
Official record key
device-enforcement:Z-1111-2017

Official wording

Reason: Organ preservation fluid recalled due to potential for bacterial contamination.

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

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination