EHOB, Inc. 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

Recommended Action

Per FDA guidance

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 .