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MARCH 16, 2017

FDA Issues Advice About Organ Recovery Fluid Recall

By SPC News Staff

The FDA has sent a warning to surgeons, infectious disease specialists, transplantation staff and risk managers about possible contamination of lots of SPS-1 Static Preservation Solution made by Organ Recovery Systems, and urged them to be extra vigilant until the problem is fixed.

To date, there have been no reports to the FDA of any postoperative infections or other adverse events directly linked to the identified products, but there is a risk, the FDA said.