Medical Device Safety and Recalls: FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication

Today, March 9, 2017, the FDA issued a Safety Communication titled "FDA Warns of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc."

SPS-1 Static Preservation Solution (SPS-1), distributed by Organ Recovery Systems, Inc., is a clear to light yellow, sterile solution intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

In this safety communication, the FDA wants to heighten awareness about the potential for bacterial contamination of SPS-1, and provide recommendations to health care facilities to help mitigate potential patient exposure to infectious bacteria. In addition, the FDA is calling attention to Organ Recovery Systems’ recall of specific SPS-1 lots and the company’s temporary suspension of production and distribution of all SPS-1 products.

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