FDA Recall Open, Classified

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

Recall: Z-2469-2021 · Initiated August 4, 2021

Recall

Recall Number
Z-2469-2021
Event Number
88483
Firm
Mac Medical Supply Co Inc
FEI Number
3004963952
Product Code
ITX
Status
Open, Classified
Root Cause
Process control
Initiated
August 4, 2021
Address
9200 Calumet Ave, Ste NW08, Munster, IN, 46321-0047

Description

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

Reason

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

Action

Email notification was made to consignees on 08/25-26/2021. The recall is extended to all customers which includes distributors, medical facilities, retail and users. Customers are asked to identify their impacted customers and forward the recall notification to those customers that have received impacted product. Customers are asked to destroy all affected product at their facility and return the recall response form. Customers are advised that destruction of product should render it unusable. Customers must contact MAC Medical Supply to confirm receipt of the notice and that they are proceeding with the recall via email, [email protected]. To contact MAC Medical Supply directly with questions, call 800-523-8337, ask for recall coordinator.

Distribution

United States Nationwide distribution.

Quantity

100,114 units