Events

Recall of Device Recall Karma

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karman Healthcare Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1025-2016
  • Event Initiated Date
    2016-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143292
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, mechanical - Product Code IOR
  • 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 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 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.

Device

Device Recall Karma
  • Model / Serial
    Item #  935-0245H6 Flexx (KM852216) Serial #  TM14-A03982-TM14-A03991  Item # 935-0246H6 Flexx (KM852218) Serial #  TM14-A03992-TM14-A04012  Item # 935-0247H6 Flexx (KM852220) Serial #  TM14-A4013-TM14-A04017
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following states -- WA, CA, NY, and TX.
  • Product Description
    Karma Flexx Wheelchair || Manual Wheelchair.
  • Manufacturer
    Karman Healthcare Inc

Manufacturer

Karman Healthcare Inc
  • Manufacturer Address
    Karman Healthcare Inc, 19255 San Jose Ave, City of Industry CA 91748-1418
  • Manufacturer Parent Company (2017)
    Karman Healthcare Inc
  • Source
    USFDA