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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Mattress Model 5185 and 5185XL used with IVC and ValueCare Series Beds see related information
Date Initiated by Firm August 29, 2007
Date Posted September 12, 2010
Recall Status1 Terminated 3 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 FL 32773
For Additional Information Contact
407-321-5630
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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