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Terminated

Assist Bed Rail - 6632

FDA Recall Z-2218-2017 · Posted 2017-06-01

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeN/A
Date Initiated2017-04-25
Date Terminated2018-01-16
Product Quantity5,020 Units

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.

Firm Action

On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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