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In this edition of Quick Notes, the FDA has elevated four device recalls to Class I, including an infusion pump that has caused six injuries and one death, two PCB-leaching brands of dialysis tubing, and an anesthesia machine that might simply shut off if used on battery power.
This week, the European Parliament adopted the European Commission’s (EC) proposal to grant more time for companies to come into compliance with 2022’s In Vitro Diagnostic Medical Devices Regulation (IVDR).
Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production.