Recall Z-0148-2010 ยท FPP Stretcher, Hand-Carried
Stryker Medical Div. of Stryker Corporation
Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251.
| Date | Nov 9, 2009 (initiated Sep 2, 2009) |
| Status | Terminated |
| Reason | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. |
| 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 ( |
| Quantity | 65 |
| Distribution | Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.