Summary
The FDA issued a Class I for LiquaSonic Ultrasound Gel 250mL, Model No. 001205 by Athena Medical Products Inc. 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-2391-2021
Action Date
2021-09-15
Status
Terminated
Category
device
Product Description
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Lot/Code Info: UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.
Quantity Affected: 12,240 cases of 12
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
Distributed to one distributor within the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-20
Company
Cincinnati, OH
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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Athena Medical Products Inc has 2 FDA actions in our database, including 2 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 (Athena Medical Products Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Athena Medical Products Inc have FDA actions?
Athena Medical Products Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2391-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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