LiquaSonic Ultrasound Gel 250mL, Model No. 001205
FDA Recall Z-2391-2021 · Posted 2021-09-09
Recalling FirmAthena Medical Products Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2021-08-20
Date Terminated2023-02-02
Product Quantity12,240 cases of 12
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.
Firm Action
On August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed.
Athena will no longer purchase or distribute products manufactured by Eco-Med.
If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email [email protected].
Root Cause
Process control
Distribution Pattern
Distributed to one distributor within the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.