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U.S. Department of Health and Human Services

Class 2 Device Recall Karma

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  Class 2 Device Recall Karma see related information
Date Initiated by Firm January 27, 2016
Create Date February 27, 2016
Recall Status1 Terminated 3 on June 29, 2016
Recall Number Z-1025-2016
Recall Event ID 73159
510(K)Number K002167  
Product Classification Wheelchair, mechanical - Product Code IOR
Product Karma Flexx Wheelchair

Manual Wheelchair.
Code Information 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 
Recalling Firm/
Manufacturer		 Karman Healthcare Inc
19255 San Jose Ave
City of Industry CA 91748-1418
For Additional Information Contact
626-581-2235
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 35
Distribution U.S. distribution to the following states -- WA, CA, NY, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = KARMAN HEALTHCARE, INC.
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