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U.S. Department of Health and Human Services

Class 2 Device Recall CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds

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 Class 2 Recall
CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds
see related information
Date Posted September 12, 2010
Recall Status1 Terminated on September 13, 2010
Recall Number Z-2402-2010
Recall Event ID 56336
Product Classification Cover, Mattress (Medical Purposes) - Product Code FMW
Product 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: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,
Code Information September 2006 through July 2007.
Recalling Firm/
Manufacturer
Invacare Corporation
2101 E. Lake Mary Blvd.
Sanford, Florida 32773
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: 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 and document your actions on the enclosed tracking sheet. 2) Return of the Product Tracking Report indicating disposition of the recalled product and acknowledgement of receipt of the recall package. 3) The tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credit. or B) 1) contact Customer Service and request part No. 6022, which is a kit that contains a 2" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements." 2) When you have completed placing the label and foam topper on all of your affected mattresses, return the tracking sheet to us and we will credit your account $10 for each mattress you have listed. the tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credi.
Quantity in Commerce 19143
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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