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Class 2 Device Recall Invacare bariatric bed |
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Date Initiated by Firm |
June 23, 2011 |
Date Posted |
November 14, 2011 |
Recall Status1 |
Terminated 3 on July 02, 2013 |
Recall Number |
Z-0187-2012 |
Recall Event ID |
59461 |
Product Classification |
bed - Product Code LLI
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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
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For Additional Information Contact |
440-329-6595
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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.
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FDA Determined Cause 2 |
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
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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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