Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC...
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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
