Recall Z-2218-2017 ยท N/A
Invacare Corporation
Assist Bed Rail - 6632
| Date | Jun 1, 2017 (initiated Apr 25, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.