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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical StairPRO Evacuation Chair

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 Class 2 Device Recall Stryker Medical StairPRO Evacuation Chairsee related information
Date Initiated by FirmNovember 18, 2008
Date PostedFebruary 04, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall NumberZ-0650-2009
Recall Event ID 50178
Product Classification patient transport device, - Product Code FPP
ProductStryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
800-869-0770 Ext. 6902
Manufacturer 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 2		Process control
ActionConsignees 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 in Commerce102
DistributionWorldwide Distribution: USA, India, Netherlands and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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