FDA Enforcement Class II Terminated

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.

Recall: Z-0634-2014 · Reported January 15, 2014

Enforcement

Recall Number
Z-0634-2014
Event ID
67134
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Invacare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Visit
Report Date
January 15, 2014
Initiation Date
April 16, 2012
Classification Date
January 7, 2014
Termination Date
January 10, 2014
Address
1 Invacare Way, Elyria, OH, 44035-4190, United States

Description

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.

Reason

The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

Code Info

Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.

Distribution

US Distribution: Michigan only.

Quantity

227 Wheelchairs