EHOB, Inc. recalls Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general c…

Recall date

January 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1457-2020

FDA classification

Class II

Brand / firm

EHOB, Inc.

Sold / distributed

US Nationwide distribution in the state of TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.