Organ Recovery Systems Under FDA mandated product Recall of SPS-1

MedDevice International.

Organ Recovery Systems, the makers of the LifePort® Kidney perfusion system and a supplier of SPS-1® Organ Preservation Solution continues to be plagued with serious manufacturing issues, and remains under an FDA Warning following the identification of several poor grades from FDA inspections.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151877

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545810.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555755.htm

http://www.empr.com/safety-alerts-and-recalls/organ-kidney-liver-pancreas-transplant-preservation/article/643194/

http://www.ishlt.org/ContentDocuments/2017JanLinks_Pouch.htm