FDAClass IOctober 20, 2021

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel recall: Contamination

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

Why was EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08

Product
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Recalling firm
Red Medical Supplies
Quantity
2000
Distribution
Firm sold product through Amazon.com. Domestic distribution nationwide.
Recall date
October 20, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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