EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Summary
The FDA issued a Class I for EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU by Red Medical Supplies. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Lette.
Details
Source
Device Recall
External ID
Z-0090-2022
Action Date
2021-10-20
Status
Ongoing
Category
device
Product Description
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Lot/Code Info: All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Quantity Affected: 639
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.
Distribution
Firm sold product through Amazon.com. Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-11
Company
Vancouver, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Red Medical Supplies has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Red Medical Supplies) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Red Medical Supplies have FDA actions?
Red Medical Supplies has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0090-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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