Recall Z-1081-2016— Stryker Medical Division of Stryker Corporation

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2015-12-03, terminated 2017-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II¿, Secure II/3¿, InTouch¿, and Epic II¿ 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.. Reason: Potential for power cord to melt; hazards include electric shock and fire..

Recalling firm

Stryker Medical Division of Stryker Corporation

Classification

Class II

Status

Terminated

Initiated

2015-12-03

Terminated

2017-05-24

Firm location

Portage, MI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.