Athena Medical Products Inc Recall 88540
Description: LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Athena Medical Products Inc Recall 88540 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2391-2021 |
| Event ID | 88540 |
| Event Description | LiquaSonic Ultrasound Gel 250mL, Model No. 001205 |
| Product Type | Devices |
| Distribution | Distributed to one distributor within the US. |
| Quantity | 12,240 cases of 12 |
| Recall Reason | 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. |
| Device Classification | 20210915 |
| Device Code Info | UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced. |
| Center Classification Date | 20210909 |
| Recall Initiation Date | 20210820 |
| Recalling Firm | Athena Medical Products Inc |
| Initial Notification | |
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