Petition to Ban Bedside Assistant Bed Handles, Model Numbers BA10W and BA10W-6, Manufactured by Bed Handles, Inc.

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Public Citizen petitions the Food and Drug Administration (FDA) to immediately ban the marketing of Bedside Assistant® bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles, Inc., because these devices have directly caused the deaths of at least four adult patients through entrapment and subsequent strangulation or positional asphyxia and therefore present “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law.

December 19, 2013, FDA final response to original petition.