LiquaSonic Ultrasound Gel 5L, Model No. 001222
Check against the official notice below — it lists the full affected range.
Athena Medical Products Inc is recalling LiquaSonic Ultrasound Gel 5L, Model No. 001222, because the product manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The affected product has UDI 00856589006137 and includes all lot codes. Approximately 480 cases of 4 units were distributed to one distributor within the United States. The product will be discontinued and will not be reintroduced.
The FDA published a Letter to Health Care Providers on August 18, 2021, addressing this contamination issue. The record does not specify a remedy or action that affected consumers 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: 480 cases of 4 Lot/code info: UDI 00856589006137, 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.