Recall Z-0148-2010
Stryker Medical Div. of Stryker Corporation · initiated September 2, 2009
Product
Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251.
Codes / lots: Serial numbers 080639995, 080640003, 081039395, 080639996, 080640004, 081039396, 080639997, 080739856, 081039397, 080639998, 080739857, 081039398, 080639999, 080739858, 081039399, 080640000, 080739859, 081039400, 080640001, 080739860, 081039401, 080640002, 080740001, 081039402, 080439860, 080439861, 080439862, 080439863, 080439864, 080439865, 080439866, 080439867, 080441124, 080439868, 080541216, 080541293, 080541294, 080541295, 080541296, 080541297, 080541298, 081039403, 081039404, 081040900, 081040901, 081040902, 090139365, 090139366, 090139367, 090139368, 090139369, 090139373, 090140687, 090140691, 090140692, 090140693, 090140694, 090140688, 090140695, 090140689, 090140696, 090140690, 090241071, 090241072 and 090241073.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0148-2010
- Initiated
- September 2, 2009
- Posted by FDA
- November 9, 2009
- Terminated
- February 16, 2011
- Product code
- FPP – Stretcher, Hand-Carried
- Quantity
- 65
- Distribution
- Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.
- Recalling firm
- Stryker Medical Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0149-2010 | Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport…The front of the handle may become detached from the chair, which could result in a patient fall or an… | 09/02/2009Terminated |