Recall Z-0648-2009
Stryker Medical Div. of Stryker Corporation · initiated November 18, 2008
Product
Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.
Codes / lots: Serial numbers 080940844, 080940845, 080940858, 080940819, 080940820 and 080940640.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0648-2009
- Initiated
- November 18, 2008
- Posted by FDA
- February 4, 2009
- Terminated
- October 27, 2010
- Product code
- FPP – Stretcher, Hand-Carried
- Quantity
- 6
- Distribution
- Worldwide Distribution: USA, India, Netherlands and United Kingdom.
- Recalling firm
- Stryker Medical Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0649-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport…Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or… | 11/18/2008Terminated |
| Z-0650-2009 | Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport…Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or… | 11/18/2008Terminated |