Device product
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Z-2391-2021
Product summary
- Event
- Event 88540
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,240 cases of 12
- Official record key
device-enforcement:Z-2391-2021
Official wording
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.
Code information: UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.
Distribution pattern: Distributed to one distributor within the US.
Derived failure modes
-
Microbial contamination
bacterial contamination