Recall Z-2403-2010

Invacare Corporation · initiated August 29, 2007

Terminated

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.

Codes / lots: Model 5185 and 5185XL

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

FDA-determined cause: Device Design

Action taken

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.

Details

Recall number
Z-2403-2010
Initiated
August 29, 2007
Posted by FDA
September 12, 2010
Terminated
September 13, 2010
Product code
FMW – Cover, Mattress (Medical Purposes)
Quantity
4896
Distribution
Nationwide Distribution
Recalling firm
Invacare Corporation, Sanford, FL

Official FDA recall record