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Devices
Device Recall SPS1, Static Preservation Solution (UW Solution)
Model / Serial
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
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
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.
1 Event
Recall of Device Recall SPS1, Static Preservation Solution (UW Solution)
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Manufacturer
Organ Recovery Systems, Inc.
Manufacturer Address
Organ Recovery Systems, Inc., 1 Pierce Pl Ste 475, Itasca IL 60143-1253
Manufacturer Parent Company (2017)
Organ Recovery Systems Inc.
Source
USFDA
Language
English
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