Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0648-2009

Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251

Stryker Medical / initiated 2008-11-18 / Terminated / root cause: manufacturing process

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251 on . The reason FDA records is "Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0648-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.
Product code
FPP Stretcher, Hand-Carried
Reason for recall
Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.
Quantity in commerce
6
Distribution
Worldwide Distribution: USA, India, Netherlands and United Kingdom.
Product codes and lots
Serial numbers 080940844, 080940845, 080940858, 080940819, 080940820 and 080940640.