AMTEC SALES Inc recalls EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmis…

Recall date

August 12, 2021

Source

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

Recall number

Z-2480-2021

FDA classification

Class I

Brand / firm

AMTEC SALES Inc

Sold / distributed

Worldwide Distribution to US (nationwide) states of - FL, TX, OH, MD, PA, WA, CO, PR, VA, KY, OK, and CA; and OUS (international) to countries of - Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica.

Why it was recalled

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.