Recall Z-2469-2021 ยท ITX Transducer, Ultrasonic, Diagnostic
Mac Medical Supply Co Inc
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
| Date | Aug 4, 2021 |
| Status | Open, Classified |
| Reason | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Root cause | Process control |
| 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 pr |
| Quantity | 100,114 units |
| Distribution | United States Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., Feb 21, 1996 |