Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35910
  • Event Risk Class
    Class 2
  • Event Number
    Z-1486-06
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47131
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    manual wheelchair - Product Code IOR
  • Reason
    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.
  • 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.

Device

Device Recall Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite.
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA