Karma Flexx Wheelchair Manual Wheelchair.
FDA Recall Z-1025-2016 · Posted None
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Recalling FirmKarman Healthcare Inc
Recall StatusTerminated
Product CodeIOR
Date Initiated2016-01-27
Date Terminated2016-06-29
Product Quantity35
Reason for Recall
Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
Firm 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.
Root Cause
Employee error
Distribution Pattern
U.S. distribution to the following states -- WA, CA, NY, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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