Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Econocare Plus Overlay

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


New Search Back to Search Results
 Class 2 Device Recall Econocare Plus Overlaysee related information
Date Initiated by FirmJanuary 19, 2020
Create DateMarch 09, 2020
Recall Status1 Terminated 3 on August 05, 2020
Recall NumberZ-1457-2020
Recall Event ID 84897
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
ProductEconocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.
Code Information Master Lot # 932213A, Product Lot Code 932243A
Recalling Firm/
Manufacturer		 EHOB, Inc.
250 N Belmont Ave
Indianapolis IN 46222-4265
For Additional Information ContactAaron Kadel
317-616-1179
Manufacturer Reason
for Recall		Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- controlled product (# 932243A). This nonconformance has the potential to expose the end user to materials deemed to be a health risk. Firm is aware of zero instances of contamination in distributed products that have reached consignees.
FDA Determined
Cause 2		Material/Component Contamination
ActionEHOB, Inc. issued a "Voluntary Medical Device Recall" letter dated January 19, 2020 via email. Letter provides identification of the issue, health risk and action to take. Distributor was advised that the products have the potential to expose patients, health care providers, or other persons when handling them unpackaged, to dried bodily fluids and told products should not be removed from their boxes as they are packaged in an arrangement to eliminate exposure via individually sealed plastic bag containers inside the corrugate box. Do not open the sealed plastic bags that the products are contained in. This product is to be returned to the EHOB Indianapolis Distribution Center at the address listed below. Please contact our Customer Service department at customerservice@ehob.com or (317) 972-4600 to arrange free return shipment. For additional information regarding this notice, you may contact Aaron Kadel, Vice President Engineering and Quality at (800) 899-5553; Monday  Friday 9 AM  4 PM EST. Medical Device Recall Return Response provided with letter - Response is required.
Quantity in CommerceU.S. (TX)
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC 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.
-
-