Recall Z-0029-2022— Aesthetics Systems Usa Inc

Name: FDA recall Z-0029-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-23

Class I · Ongoing

Class I FDA medical device recall by Aesthetics Systems Usa Inc, initiated 2021-08-23. It names one FDA 510(k) clearance: K955246. Product: Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.. 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..

Recalling firm: Aesthetics Systems Usa Inc
Classification: Class I
Status: Ongoing
Initiated: 2021-08-23
Firm location: Corona, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K955246 — ECOGEL 200 ULTRASOUND GELEco-Med Pharmaceuticals, Inc.·cleared 1996-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.