Product Description IsoGel AIR 84, Support Surface. Intended to assist in
improving human patient outcomes.

Recall Number Z-1946-2013

Classification Class II

For specific recall item numbers please go to: FDA Recalls Enforcement Report - Week of August 21, 2013

Product Distributed Qty 586 units

Reason For Recall Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubing subassembly. All IsoGel AIR" Support Surfaces come equipped with integrated Low Air Loss (LAL) tubing. Low Air Loss functionality is available only if the surface is connected to the optional Stryker Air Pump.

Event Detail

Event Id 65337

Product Type Devices

Status Ongoing

Recalling Firm

Stryker Medical Division of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-07-12

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide Distribution-USA including the states of OH, ME, IL, CO , FL, TX, MI, GA, and VA