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U.S. Department of Health and Human Services

Class 2 Device Recall EHOB Waffle Overlay

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  Class 2 Device Recall EHOB Waffle Overlay see related information
Date Initiated by Firm April 19, 2021
Create Date June 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-1950-2021
Recall Event ID 87864
Product Classification Mattress, flotation therapy, non-powered - Product Code IKY
Product Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort.
Product Code: 1025ECP
Code Information Lot Number: 105013A
Recalling Firm/
Manufacturer		 EHOB, Inc.
250 N Belmont Ave
Indianapolis IN 46222-4265
For Additional Information Contact SAME
317-972-4600
Manufacturer Reason
for Recall		 Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
FDA Determined
Cause 2		 Process control
Action EHOB issued recall notification Urgent Medical Device Recall letter 0n 4/19/21 via electronically tracked signature documents. The letter states reason for recall, health risk and action to take: Products should not be removed from their box 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 recall notice is temporary, is limited to the identified lot of this product, and does not cause a shortage of availability. Additionally, all other lot numbers of this product are safe for use and available for distribution. 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 .
Quantity in Commerce 70 units
Distribution US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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