EHOB, Inc. recalls Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, ass…

Recall date

June 9, 2020

Source

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

Recall number

Z-2640-2020

FDA classification

Class II

Brand / firm

EHOB, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

QC inspection observed that a portion of the lot may have been contaminated with blood.

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

What was recalled

Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.