Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2403-2010

Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL...

Invacare GmbH / initiated 2007-08-29 / Terminated / root cause: design

Invacare Corporation began a recall of Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in... on . The reason FDA records is "In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2403-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
Product code
FMW Cover, Mattress (Medical Purposes)
Reason for recall
In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a
Root cause tag
design
FDA root cause
Device Design
Action
Consignees of the product were notified by letter dated 09/05/2007. Consignees were instructed to destroy the affected mattresses and to return the completed confirmation of the destruction form to Invacare.
Quantity in commerce
4896
Distribution
Nationwide Distribution
Product codes and lots
Model 5185 and 5185XL