FDAnews
www.fdanews.com/articles/130478-fda-mhra-recall-devices

FDA, MHRA Recall Devices

September 22, 2010
The FDA has deemed a recall for the Symbiq One and Two-Channel Infusers a Class I recall. The infusion pumps, manufactured by Hospira, have demonstrated a potential for unrestricted flow of fluid or medication. The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for the Delta and Gamma XXL, a vital signs monitor manufactured by Draeger Medical. The monitor’s keypad may become inoperative or enter keystrokes unintentionally.