FDA Recall Terminated

Karma Flexx Wheelchair Manual Wheelchair.

Recall: Z-1025-2016 · Initiated January 27, 2016

Recall

Recall Number
Z-1025-2016
Event Number
73159
Firm
Karman Healthcare Inc
FEI Number
1000306460
Product Code
IOR
Status
Terminated
Root Cause
Employee error
Initiated
January 27, 2016
Terminated
June 29, 2016
Address
19255 San Jose Ave, City of Industry, CA, 91748-1418

Description

Karma Flexx Wheelchair Manual Wheelchair.

Reason

Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.

Action

On 01/27/16 the firm sent out customer notification letters. In the letter customers were informed that the firm was conducting a product update for original purchasers of KM8522. Customers were provided the following procedures for the product update: 1. Completed and signed notification must be returned to Karman Healthcare via fax at (626)-581-2335, or e-mail to [email protected]. 2. Following the received frame, customers may install their current wheels, and footrest onto the newly updated frame. Kindly package the used frame into the carton in the same manner the new carton was shipped. 3. A prepaid return shipping label is included with the letter, which customers may use to return the carton; or contact the firm's customer service line at (800)-805-2762 to have a trained representative schedule a pickup at no charge.

Distribution

U.S. distribution to the following states -- WA, CA, NY, and TX.

Quantity

35