Medical Device
Manufacturing
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Z-0187-2012

Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC...

Invacare GmbH / initiated 2011-06-23 / Terminated / root cause: labeling and UDI

Invacare Corporation began a recall of Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0187-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
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.
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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.
Root cause tag
labeling and UDI
FDA root 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.
Product codes and lots
Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG. 35747 serial numbers available from Invacare.