Z-2218-2017 Class II Terminated
FDA device recall Z-2218-2017 was initiated by Invacare Corporation on April 25, 2017 and is designated Class II. Reason for recall: A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly. The recall status is terminated (terminated January 16, 2018). Affected quantity: 5,020 Units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 25, 2017
- Termination Date
- January 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,020 Units
Product Description
Assist Bed Rail - 6632
Reason for Recall
A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.
Distribution Pattern
Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
Code Information
MN: 6632; Date Code begging with FT150701 through FT170228