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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