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Athena Medical Products Inc Recall 88540

Description: LiquaSonic Ultrasound Gel 5L, Model No. 001222

Athena Medical Products Inc Recall 88540 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2392-2021
Event ID88540
Event DescriptionLiquaSonic Ultrasound Gel 5L, Model No. 001222
Product TypeDevices
DistributionDistributed to one distributor within the US.
Quantity480 cases of 4
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 Classification20210915
Device Code InfoUDI 00856589006137, All lot codes. Product will be discontinued and will not be reintroduced.
Center Classification Date20210909
Recall Initiation Date20210820
Recalling FirmAthena Medical Products Inc
Initial Notification E-Mail
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