December 22, 2016 FAQs

FAQs About Voluntary Product Removal of SPS-1 Lot PBR-0074-330 & Lot PBR-0060-392

Updated: December 22, 2016

Q: How many times has this happened?
A: The reported incident under investigation regarding Lot Number PBR-0060-392 was the first report of this kind; Lot Number PBR-0074-330 was also included out of an abundance of caution.
 
Q: Was anyone hurt?
A: Not to our knowledge. We have not received any information demonstrating that anyone was harmed by using our products that are part of the incident report that we are investigating.
 
Q: How many Lots were affected?
A: We have identified the Lot Numbers (Lot Numbers PBR-0060-392 and PBR-0074-330) for 2 separate bags of SPS-1, Static Preservation Solution that were reported by a third party claiming a certain uncharacteristic odor suggestive of potential contamination. The reports we received did not confirm the source of the odor or the presence of contamination of our products. We are told by the reporting party that the actual units of SPS-1, Static Preservation Solution referenced in the report and samples therefrom were disposed of by the reporting party, and therefore we have not had the opportunity to conduct independent testing of the actual units upon which these reports were based. We are in the process of conducting a thorough investigation of remaining units from each of the referenced Lots.
 
Q: Why did you decide to remove these Lots?
A: We decided to voluntarily remove all units from these 2 Lots out of an abundance of caution pending a full investigation. Both Lot Numbers PBR-0074-330 and PBR-0060-392 met all of our rigorous product release criteria, including for sterility, before being released for distribution and clinical use. Release criteria procedures include required testing for sterility, cytotoxicity, systemic injection, endotoxin, particulate count, pH measurement, osmolality measurement, and chemical analysis. Our precautionary decision is in response to an incident reported to us of an uncharacteristic odor being attributed to our products. At this time, neither the source of the odor nor the presence of contamination are confirmed.

Q: Why don’t you remove all of your SPS-1, Static Preservation Solution products and not just the units from Lot Number PBR-0060-392 and Lot Number PBR-0074-330?
A: We have no basis for such an action as Organ Recovery Systems has not received any product complaints that would warrant such action. All of our products are manufactured in the US, in a US FDA approved manufacturing facility designed and certified for making SPS-1, Static Preservation Solution per its US FDA cleared solution formulation as outlined in the product’s Instructions for Use. Prior to release for clinical use, these products are required to undergo rigorous quality testing, including required sterility validation and verification procedures. Product release criteria procedures includes required testing for sterility, cytotoxicity, systemic injection, endotoxin, particulate count, pH measurement, osmolality measurement, and chemical analysis. Out of an abundance of caution, we decided to voluntarily remove all units from the 2 Lots in question pending a full investigation. This concern is born of an isolated incident reported to us and based upon unconfirmed information from third parties.
 
Q: How quickly can you arrange for me to obtain replacement products?
A: Immediately. Our Customer Service desk can assist you to facilitate the return and ordering of replacement products.
 
Q: Have you notified the FDA?
A: Yes. Our decision to remove our product though is voluntary based upon Organ Recovery Systems exercising an abundance of caution, and not mandated by the FDA. We are working closely with FDA, HRSA, and all appropriate regulatory agencies as required.