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

FDA device recall Z-1946-2013 · posted 2013-08-09 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

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 tubi

Action taken

On 7/12/13, an URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees. The notification addressed the affected product and issue, potential hazard, actions needed including faxing (269-488-8691) or emailing (ProductFieldAction@stryker.com) the attached reply form to confirm receipt of notification, and risk mitigation. Please contact the firm at 269-389-8129 if you have questions or concerns regarding this recall. Business hours are M-F 8am-5pm(ET).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IOQ

Quantity affected

586 units

Distribution

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

Date initiated

2013-07-12

Date posted

2013-08-09

Date terminated

2014-09-11

Location

Portage, MI