Recall Z-2403-2010 ยท FMW Cover, Mattress (Medical Purposes)
Invacare Corporation
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.
| Date | Sep 12, 2010 (initiated Aug 29, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 4896 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.