Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Ec
Summary
The FDA issued a Class I for Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound G by Mac Medical Supply Co Inc. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..
Details
Source
Device Recall
External ID
Z-2469-2021
Action Date
2021-09-29
Status
Ongoing
Category
device
Product Description
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
Lot/Code Info: Item Numbers: 1) 001205 (LiquaSonic Ultrasound Gel, 8.5oz) 2) 001222 (LiquaSonic Ultrasound Gel, 5L) 3) 30GB (EcoGel 100, 250ml, 12/cs) 4) 5005L4 (MAC EcoGel 5L, 4/cs) 5) 500812 (MAC EcoGel, 250ml, 12/cs) 6) M50008 (MediChoice Empty 8oz bottle) 7) M5005L4 (MediChoice USG 5L, 4/cs) 8) M500812 (MediChoice, 250ml, 12/cs) 9) 50TB (EcoGel High V TENS, 250ml) 10) 40JBB (EcoGel Multipurpose Ultrasound Gel, 250ml, 8oz, 12/cs) 11) 40JBHV-24 (EcoGel Blue High Velocity Ultrasound Gel, 250ml, 24/cs) 12) 40JMC (EcoGel 200 MultiPurpose Clear Ultrasound Gel 4-5ml Cubes with 4 dispenser bottles, 5L, 4/cs) 13) 20400 (MAC Ultrasound Gel Packet - Multipurpose) All lots shipped between 08/2018 and 08/2021.
Quantity Affected: 100,114 units
Reason for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Distribution
United States Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-04
Company
Munster, IN
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 173 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 (Mac Medical Supply Co Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mac Medical Supply Co Inc have FDA actions?
This is the only FDA action we have on record for Mac Medical Supply Co Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2469-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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