LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Check against the official notice below — it lists the full affected range.
Athena Medical Products Inc is recalling LiquaSonic Ultrasound Gel 250mL (Model No. 001205) because the product, manufactured by Eco-Med Pharmaceutical, Inc., may contain bacterial contamination. The FDA published a Letter to Health Care Providers on August 18, 2021 addressing this contamination issue. The affected product has UDI 00856589006120 and includes all lot codes. Approximately 12,240 cases of 12 units were distributed to one distributor within the United States.
The product will be discontinued and will not be reintroduced. The source document does not specify a remedy or instructions for affected consumers regarding what actions they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Distributed to one distributor within the US. Quantity: 12,240 cases of 12 Lot/code info: UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.