Recall Z-0650-2009
Stryker Medical Div. of Stryker Corporation · initiated November 18, 2008
Product
Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.
Codes / lots: Serial numbers 080940895, 080940896, 080940578, 080940614, 080940615, 080940616, 080940618, 080940619, 080940620, 080940621, 080940623, 080940624, 080940625, 080940626, 080940628, 080940880, 080940571, 080940572, 080940573, 080940574, 080940575, 080940576, 080940629, 080940630, 080940599, 080940554, 080940555, 080940887, 080940888, 080940889, 080940890, 080940891, 080940892, 080940893, 080940894, 800940881, 080940772, 080940773, 080940774, 080940564, 080940565, 080940566, 080940850, 080940856, 080940556, 800940557, 080940558, 080940559, 080940560, 080940561, 800940562, 080940563, 080940633, 080940634, 080940635, 080940636, 080940245, 080940246, 080940851, 080940852, 080940853, 080940854, 080940846, 080940847, 080940848, 080940849, 080940810, 080940811, 080940812, 080940813, 080940814, 080940815, 080940577, 080940631, 080940632, 080940617, 080940622, 080940627, 080940818, 080940857, 080940882, 080940897, 080940816, 080940817, 080940567, 080940568, 080940569, 080940570, 080940579, 080940800, 080940801, 080940802, 080940878, 080940879, 080940855, 080940883, 080940884, 080940885, 080940886, 080940637, 080940638 and 080940803.
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-0650-2009
- Initiated
- November 18, 2008
- Posted by FDA
- February 4, 2009
- Terminated
- October 27, 2010
- Product code
- FPP – Stretcher, Hand-Carried
- Quantity
- 102
- 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-0648-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.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-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 |