Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
This recall is currently active, issued August 25, 2021. It was issued by Accelerated Care Plus Corporation.
- Recall Initiated
- August 25, 2021
- Recall Number
- Z-2518-2021
- Quantity
- 9436
- Firm Location
- Reno, NV
- Official Source
- View on FDA website ↗
Reason for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Distribution
US nationwide distribution.
Lot / Code Info
Distributed from January 1, 2018 thru August 4, 2021
Root Cause
Process control
Action Taken
On 08/25/2021, Medical Device Recall notices were mailed and emailed to customers who were asked to take the following actions: Immediately stop use of all Eco-Med products. - Destroy and render unusable all affected products that you received from ACPL, by disposing the gel along with your general medical waste. - Carefully read the Recall Notice and follow the instructions, including completing the Eco-Med Product Recall Response Form indicating that you have read the recall notice and will take appropriate action including documenting the quantity of product in inventory and the quantity destroyed. - If you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Customers with additional questions or concerns can call Customer Support at 800.350.1100.