Health Canada — Medical Devices · Canada · 2022-12-21 · Type II
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Reported risk: Clients have reported several cases of patients having inflammatory reactions after injection with platelet-rich plasma (PRP), characterized by joint effusion and/or pain. Particles in the sodium citrate solution have been observed, with an irregular appearance of the separation gel and the presence of a white layer on the gel surface. To clarify, the separation gel is used for blood separation. It creates a physical barrier between the red blood cells and the PRP. Only the plasma is reinjected into the patient; the gel is not. Recall start date: August 2, 2022
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