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U.S. Department of Health and Human Services

Class 2 Device Recall Assist Bed Rail

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  Class 2 Device Recall Assist Bed Rail see related information
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.
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