Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0149-2010

Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252

Stryker Medical / initiated 2009-09-02 / Terminated / root cause: design

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252 on . The reason FDA records is "The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0149-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.
Product code
FPP Stretcher, Hand-Carried
Reason for recall
The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.
Root cause tag
design
FDA root cause
Device Design
Action
Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.
Quantity in commerce
165
Distribution
Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.
Product codes and lots
Serial numbers 080340370, 080340371, 080340372, 080340373, 080340374, 080340375, 080340376, 080340377, 080340378, 080340379, 080340380, 080340381, 080340382, 080340383, 080340384, 080340385, 080340386, 080340387, 080340388, 080340389, 080439732, 080539750, 080539751, 080539752, 080539755, 080539756, 080539757, 080540101, 080540102, 080540103, 080540104, 080540105, 080540106, 080540107, 080540108, 080540109, 080540110, 080540111, 080540112, 080540113, 080540114, 080540115, 080541118, 080541119, 080541120, 080541121, 080541122, 080541123, 080541124, 080541125, 080541126, 080541127, 080541128, 080541129, 080541130, 080541131, 080541132, 080541163, 080541164, 080541165, 080541166, 080541167, 080541168, 080541169, 080541170, 080541171, 080541172, 080541173, 080541174, 080541175, 080541176, 080541177, 080541188, 080541189, 080541190, 080541223, 080541224, 080541225, 080541226, 080541227, 080541228, 080541229, 080541230, 080541231, 080541232, 080541233, 080541234, 080541235, 080541236, 080541237, 080541238, 080541239, 080740000, 080839665, 080839666, 080839667, 080940219, 080940220, 080940221, 080940598, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 081040840, 081040841, 081040842, 081040843, 081139364, 081139365, 081139366, 081139367, 081139368, 081139369, 081139370, 081139371, 081139372, 081139373, 081139374, 081139375, 081139376, 081139377, 081139378, 081139664, 081140082, 081140083, 081140084, 081140085, 090140100, 090140101, 090140102, 090140103, 090140104, 090140105, 090239555, 090239587, 090240122, 090240123, 090240124, 090240125, 090240126, 090240127, 090240128, 090240129, 090240130, 090240131, 090240132, 090240133, 090240134, 090240135, 090240136, 090240137, 090240138, 090240139, 090240140, 090240141, 090240488, 090240988, 090240989, 090240990, 090240991 and 090240992.