December 18, 2016 Update

Important Information Regarding Two Separate Lots of SPS-1®, Static Preservation Solution

Updated: December 18, 2016

We are initiating a voluntary removal of two lots of SPS-1, Static Preservation Solution, Lot Number PBR-0074-330 (2-liter bag) and Lot Number PBR-0060-392 (1-liter bag).

On December 14, we voluntarily removed Lot Number PBR-0060-392. Subsequent to our notice sent on December 14, we learned that a single 2-liter bag of SPS-1, Static Preservation Solution from Lot Number PBR-0074-330 that was used at the same location as the single 1-liter bag of SPS-1, Static Preservation Solution from Lot Number PBR-0060-392, may also have been associated with an uncharacteristic odor suggesting a potential contamination. Although this information has not been substantiated, we are taking this seriously in order to ensure the safety our products.

Please note that we have verified that both Lot Numbers PBR-0074-330 and PBR-0060-392 met product release criteria, including sterility, before these Lots were released to inventory for clinical use.

While we are in the process of investigating any issues that may be affecting the performance of these products, we have also decided out of an abundance of caution to voluntarily initiate the removal of any SPS-1, Static Preservation Solution that you may have from Lot Number PBR-0074-330. Our removal actions are voluntary and precautionary measures. As we gather additional information, we will provide you further instructions as necessary.

In the meantime, if you have any product from the Lot Number PBR-0074-330, we ask that you please remove all product with this Lot Number from your inventory and do not dispose. Please keep products from Lot Numbers PBR-0074-330 and PBR-0060-392 separate.

After segregating and counting all units, please contact our Customer Service to facilitate the product return. If you have questions about this notice, please contact Matthew Copithorne at 847.824.2421.

We request that you please return all product from these Lots to the Company. When you contact us we will provide you with a return authorization code and return shipping labels. For all removed product, we will ship replacement product to you at our expense. If you would like the replacement product expedited via overnight courier, please advise and we will be glad to do so at our expense.