Atlas FDA

Assist Bed Rail - 6632

FDA device recall Z-2218-2017 · posted 2017-06-01 · Terminated

Recall details

Recalling firm
Invacare Corporation
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.
Action taken
On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.
Root cause
Under Investigation by firm
Status
Terminated
Product code
N/A
Quantity affected
5,020 Units
Distribution
Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
Date initiated
2017-04-25
Date posted
2017-06-01
Date terminated
2018-01-16
Location
Elyria, OH

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