Econocare 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.
- Company
- Ehob, Inc.
- Recall Initiated
- January 19, 2020
- Terminated
- August 5, 2020
- Recall Number
- Z-1457-2020
- Quantity
- U.S. (TX)
- Firm Location
- Indianapolis, IN
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.
Distribution
US Nationwide distribution in the state of TX.
Lot / Code Info
Master Lot # 932213A, Product Lot Code 932243A
Root Cause
Material/Component Contamination
Action Taken
EHOB, 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.