Class 1 Device Recall Omnisound gel and EcoGel

• Date Initiated by Firm: August 25, 2021
• Create Date: September 25, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2518-2021
• Recall Event ID: 88602
• 510(K)Number: K955246
• Product Classification: Transducer gel, ultrasonic, diagnostic - Product Code ITX
• Product: Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
• Code Information: Distributed from January 1, 2018 thru August 4, 2021
• Recalling Firm/ Manufacturer: Accelerated Care Plus Corporation; 4999 Aircenter Cir Ste 103; Reno NV 89502-7923
• For Additional Information Contact: 800-350-1100
• Manufacturer 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
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 9436
• Distribution: US nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.