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Infant sleep positioners are typically flat mats with side bolsters or wedge mats with side bolsters and have been commonly used to help keep babies on their backs to reduce the risk of sudden infant death syndrome (SIDS), even though the FDA has never approved that use. Consumer Product Safety Commission (CPSC), follows government reports that at least 12 babies under 4 months old suffocated in the last 13 years after being placed in a crib outfitted with a sleep positioner. Mason Sharfstein, said during an afternoon teleconference with reporters. The public health advisory, issued jointly by the U.S. "Based on the information that CPSC shared with FDA, both agencies agree and are working together to stop the use of these products and get them off the market," the FDA's principal deputy commissioner, Dr. The government also has many more reports of babies found in potentially dangerous positions after being placed in one of these products. At the moment, manufacturers of the 18 sleep positioner products that have been cleared for sale by the FDA are. All 12 died after rolling from a side to a stomach position or becoming trapped between a sleep positioner and the frame of a crib or bassinet. Food and Drug Administration (FDA) and the U.S. |