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U.S. Department of Health and Human Services

Class 2 Device Recall Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite.

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  Class 2 Device Recall Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite. see related information
Date Initiated by Firm July 18, 2006
Date Posted September 06, 2006
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-1486-06
Recall Event ID 35910
510(K)Number K982336  
Product Classification manual wheelchair - Product Code IOR
Product Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite.
Code Information 0805007204, 0805040231,0805087799, 0805191275, 0805238718, 0805528869, 0805590456, 0805007205, 0805040233, 0805094654, 0805202392, 0805260264, 0805528870, 0805590458, 0805007206, 0805046010, 0805112919, 0805202409, 0805260267, 0805528879, 0805598707, 0805007207, 0805052515, 0805112920, 0805202410, 0805265355, 0805538825, 0805606638, 0805031769, 0805052531, 0805112921, 0805208212, 0805265356, 0805547691, 0805606639, 0805032072, 0805052780, 0805142288, 0805214576, 0805488915, 0805556308, 0805606650, 0805032078, 0805059713, 0805148474, 0805220731, 0805528850, 0805556313, 0805626956, 0805032082, 0805059770, 0805171786, 0805220813, 0805528852, 0805573454, 0805636805 0805032091, 0805081690, 0805171787, 0805226782, 0805528854, 0805573455, 0805636810, 0805040230, 0805087792, 0805178698, 0805226965, 0805528856, 0805590391, 0805643631, 0805643632, 0805743810, 0805793490, 0805837237, 0805871475, 0805937131, 0806309254, 0805664651, 0805743813, 0805802652, 0805845927, 0805894716, 0805969761, 0806309260 0805671759, 0805771388, 0805802878, 0805845935, 0805894890, 0805977531, 0806309261, 0805685506, 0805776512, 0805807275, 0805850343, 0805894892, 0806273105, 0806309267, 0805702791, 0805776514, 0805807278, 0805855553, 0805900539, 0806281922, 0806315127, 0805710093, 0805780848, 0805807281, 0805860047, 0805900540, 0806281924, 0806315184 0805710275, 0805784712, 0805811158, 0805865040, 0805906053, 0806303957, 0806320300, 0805716215, 0805784713, 0805815571, 0805865041, 0805922688, 0806303963, 0806326394, 0805721816, 0805784714, 0805815575, 0805871470, 0805929066, 0806303965, 0806326395, 0805738220, 0805789076, 0805815809, 0805871471, 0805937122, 0806309167, 0806338838,  0806338840, 0806372582, 0806390080, 0806415186, 0806448589, 0805771388, 0806338842, 0806372583, 0806390081, 0806415385, 0806448735, 0806350846, 0806372585, 0806390082, 0806422077, 0806455546  0806350855, 0806372614, 0806390083, 0806428328, 0806463285, 0806355566, 0806372615, 0806396466, 0806428330, 0806463289, 0806366353, 0806372616, 0806408921, 0806428344, 0806463290, 0806366354, 0806372618, 0806408928, 0806428346, 0806480052,  0806366356, 0806372620, 0806408929, 0806428563, 0806480055, 0806366544, 0806390074, 0806408930, 0806435361, 0806480070, 0806372581, 0806390075, 0806408938, 0806441968, 0806488512.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information Contact Janice K. Brownlee
440-329-6000
Manufacturer Reason
for Recall		 If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.
FDA Determined
Cause 2		 Device Design
Action The recalling firm notified all consignees by recall letter sent on or about 7/20/06 along with replacement anti-tippers for each device on hand.
Quantity in Commerce 208 wheelchairs
Distribution Nationwide and Canada.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = INVACARE CORP.
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