Recall Z-2391-2021— Athena Medical Products Inc

Name: FDA recall Z-2391-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-20

Class I · Terminated

Class I FDA medical device recall by Athena Medical Products Inc, initiated 2021-08-20, terminated 2023-02-02. It names one FDA 510(k) clearance: K955246. Product: LiquaSonic Ultrasound Gel 250mL, Model No. 001205. 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: Athena Medical Products Inc
Classification: Class I
Status: Terminated
Initiated: 2021-08-20
Terminated: 2023-02-02
Firm location: Cincinnati, OH, 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

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

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.