Recall Z-1025-2016— Karman Healthcare Inc

Name: FDA recall Z-1025-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-27

Class II · Terminated

Class II FDA medical device recall by Karman Healthcare Inc, initiated 2016-01-27, terminated 2016-06-29. It names one FDA 510(k) clearance: K002167. Product: 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..

Recalling firm: Karman Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-27
Terminated: 2016-06-29
Firm location: City of Industry, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K002167 — KARMAN WHEELCHAIRKarman Healthcare, Inc.·cleared 2000-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Karma Flexx Wheelchair Manual Wheelchair.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.