Z-2391-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- August 20, 2021
- Termination Date
- February 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,240 cases of 12
Product Description
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
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 Pattern
Distributed to one distributor within the US.
Code Information
UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.