Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic
Summary
The FDA issued a Class II for Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument by Microcare Medical. Reason: Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria.
Details
Source
Device Recall
External ID
Z-3209-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
Lot/Code Info: Lot/Model: 2331982/GVUS128-1EA, GVUS128-1, GVUS550-1; 2332204/GVUS128-1EA, JGVUS128-1, GVUS128-1, VGVUSNP128-1EA, VGVUSNP128-1; 2332393/GVUS128-1EA, VGVUSNP128-1, GVUS24-1EA, GVUS24-1, GVUS128-1 2432755/JGVUS128-1 2432989/GVUS24-1EA, VGVUSNP128-1EA, GVUS24-1, VGVUSNP128-1, JGVUS128-1 Model/UDI-DI: GVUS128-1/+H816GVUS128H, GVUS24-1/+H816GVUSU24%, GVUS550-1/+H816GVUS550G, VGVUS128-1/+H816VGVUSNP128A, JGVUS128-1/723754044532
Quantity Affected: 1649
Reason for Recall
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Distribution
Worldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO, NY, MD, CA, MI, NE, UT, OK, WI, NJ, IL, ME, CT, KS, TX, NC, TN, SC, MO and the countries of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-29
Company
Commerce City, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Microcare Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microcare Medical have FDA actions?
This is the only FDA action we have on record for Microcare Medical in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3209-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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