• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Mattress Model 5185 and 5185XL used with IVC and ValueCare Series Beds

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Mattress Model 5185 and 5185XL 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-2403-2010
Recall Event ID 56335
Product Classification Cover, Mattress (Medical Purposes) - Product Code FMW
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.
Code Information Model 5185 and 5185XL
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 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 2
DESIGN: 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
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.
-
-