Recall Z-0648-2009 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 | Feb 4, 2009 (initiated Nov 18, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 6 |
| Distribution | Worldwide Distribution: USA, India, Netherlands and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.