Date Initiated by Firm |
April 16, 2012 |
Date Posted |
January 08, 2014 |
Recall Status1 |
Terminated 3 on January 10, 2014 |
Recall Number |
Z-0634-2014 |
Recall Event ID |
67134 |
Product Classification |
Wheelchair, mechanical - Product Code IOR
|
Product |
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035
For transportation to accomplish necessary tasks of daily living in a home or community environment for the user. |
Code Information |
Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722. |
Recalling Firm/ Manufacturer |
Invacare Corporation 1 Invacare Way Elyria OH 44035-4190
|
For Additional Information Contact |
Swasita Saigal 440-329-6875
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Manufacturer Reason for Recall |
The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
The firm, Invacare, sent a memo dated December 4, 2013 to their customer. The memo described the product, problem, and actions to be taken . On February 8, 2012 representatives from the recalling firm visited the customer to investigate the complaint. The wheelchairs were returned and destroyed.
If you have any question, please call 440-329-6875 or email: ssaigal@invacare.com. |
Quantity in Commerce |
227 Wheelchairs |
Distribution |
US Distribution: Michigan only. |
Total Product Life Cycle |
TPLC Device Report
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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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