Z-1025-2016 Class II Terminated
FDA device recall Z-1025-2016 was initiated by Karman Healthcare Inc on January 27, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 29, 2016). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2016
- Initiation Date
- January 27, 2016
- Termination Date
- June 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
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.
Distribution Pattern
U.S. distribution to the following states -- WA, CA, NY, and TX.
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