Product Safety Recalls

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Aesthetics Systems Usa Inc Recall 88624

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

Aesthetics Systems Usa Inc Recall 88624 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0029-2022
Event ID88624
Event DescriptionAction De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Quantity23
Recall ReasonUltrasound 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 Classification20211013
Device Code InfoAll lots with valid expiration dates
Center Classification Date20211006
Recall Initiation Date20210823
Recalling FirmAesthetics Systems Usa Inc
Initial Notification Letter
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