Recall Z-1025-2016 ยท IOR Wheelchair, Mechanical
Karman Healthcare Inc
Karma Flexx Wheelchair Manual Wheelchair.
| Date | Jan 27, 2016 |
| Status | Terminated |
| Reason | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. |
| Root cause | Employee error |
| 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 edward@karmanhealthcare.com. 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 carto |
| Quantity | 35 |
| Distribution | U.S. distribution to the following states -- WA, CA, NY, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002167 | KARMAN WHEELCHAIR Karman Healthcare, Inc., Aug 25, 2000 |