Recall Z-2402-2010 ยท FMW Cover, Mattress (Medical Purposes)
Invacare Corporation
CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). Manufactured by: In
| Date | Sep 12, 2010 (initiated Oct 11, 2007) |
| Status | Terminated |
| Reason | In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, when used with Invacare bed rails. Affected bed packages are BED24IVC, BED25IVC, BED24CA, and BED25CA. The mattresses when used in combination with the IVC a |
| Root cause | Device Design |
| Action | Consignees were notified of the recall by letter dated October 15, 2007 and entitled "CareGuard Mattresses Provided Since September 2006 In combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the Value Care Bed Series Semi Electric Bed, and Full and Half-Length Rails". Depending on the mattress usage the consignees were instructed to either: A: 1) Move the bed rail cross bar from the 5th and 6th spring location on the head section of the bed to the 6th and 7th spring location on the head section of the bed in accordance with the enclosed instructions an |
| Quantity | 19143 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.