FDA Enforcement
Class II
Terminated
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Recall: Z-2023-2014
·
Reported July 16, 2014
Enforcement
- Recall Number
- Z-2023-2014
- Event ID
- 68399
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Invacare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 16, 2014
- Initiation Date
- June 25, 2014
- Classification Date
- July 9, 2014
- Termination Date
- April 15, 2015
- Address
- 1200 Taylor St, Elyria, OH, 44035-6248, United States
Description
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Reason
The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.
Code Info
Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).
Distribution
Distributed in PA and Canada.
Quantity
465 units