Recall Z-2218-2017
Invacare Corporation · initiated April 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Assist Bed Rail - 6632
Codes / lots: MN: 6632; Date Code begging with FT150701 through FT170228
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.
FDA-determined cause: Under Investigation by firm
Action taken
On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.
Details
- Recall number
- Z-2218-2017
- Initiated
- April 25, 2017
- Posted by FDA
- June 1, 2017
- Terminated
- January 16, 2018
- Quantity
- 5,020 Units
- Distribution
- Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
- Recalling firm
- Invacare Corporation, Elyria, OH