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Recall Observatory FDA recall evidence

Device product

Assist Bed Rail - 6632

Z-2218-2017

April 25, 2017

Class II

Product summary

Firm
Invacare Corporation
Event
Event 77128
Status
Terminated
Classification
Class II
Quantity
5,020 Units
Official record key
device-enforcement:Z-2218-2017

Official wording

Reason: 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.

Code information: MN: 6632; Date Code begging with FT150701 through FT170228

Distribution pattern: Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.