Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultra
Summary
The FDA issued a Class I for Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; M by Accelerated Care Plus Corporation. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Lett.
Details
Source
Device Recall
External ID
Z-2518-2021
Action Date
2021-10-06
Status
Ongoing
Category
device
Product Description
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Lot/Code Info: Distributed from January 1, 2018 thru August 4, 2021
Quantity Affected: 9436
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
US nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-25
Company
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 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Accelerated Care Plus Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accelerated Care Plus Corporation have FDA actions?
This is the only FDA action we have on record for Accelerated Care Plus Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2518-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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