Class 2 Device Recall Invacare bariatric bed

• Date Initiated by Firm: June 23, 2011
• Date Posted: November 14, 2011
• Recall Status: Terminated on July 02, 2013
• Recall Number: Z-0187-2012
• Recall Event ID: 59461
• Product Classification: bed - Product Code LLI
• Product: Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG.
• Code Information: Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG. 35747 serial numbers available from Invacare.
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-6248
• For Additional Information Contact: 440-329-6595
• Manufacturer Reason for Recall: Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.
• FDA Determined Cause: Labeling design
• Action: On 9/19/11, Invacare sent Recall Notificaiton Letters to their customers. They instructed their customers to quarantine the product, complete and return a response form.
• Quantity in Commerce: 35,747
• Distribution: Distribution Nationwide and to United Arab Emirates, Dominican Republic, Egypt, Guam, Mexico, & Virgin Islands.
• Total Product Life Cycle: TPLC Device Report

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.