Miami, FL, United States
AMTEC SALES Inc recalls
1 recall recorded since 2018, most recently on 12 August 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 12 August 2021
- Reason
- Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2480-2021
- 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 tiss
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.