Class 2 Device Recall Assist Bed Rail

Date Initiated by Firm	April 25, 2017
Date Posted	June 01, 2017
Recall Status¹	Terminated ³ on January 16, 2018
Recall Number	Z-2218-2017
Recall Event ID	77128
Product Classification	unknown device name - Product Code N/A
Product	Assist Bed Rail - 6632
Code Information	MN: 6632; Date Code begging with FT150701 through FT170228
Recalling Firm/ Manufacturer	Invacare Corporation 1200 Taylor St Elyria OH 44035-6248
For Additional Information Contact	877-413-6008
Manufacturer 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.
FDA Determined Cause ²	Under Investigation by firm
Action	On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.
Quantity in Commerce	5,020 Units
Distribution	Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.