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Recall Observatory FDA recall evidence

Device product

Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

Z-0029-2022

August 23, 2021

Class I

Product summary

Firm
Aesthetics Systems Usa Inc
Event
Event 88624
Status
Ongoing
Classification
Class I
Quantity
23
Official record key
device-enforcement:Z-0029-2022

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: All lots with valid expiration dates

Distribution pattern: U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination