Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failur

Fri, 07 Oct 2022 10:09:06 -0400

Fri, 07 Oct 2022 09:29:16 -0400

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.