Microcare Medical: Device Recall

Recall #Z-3209-2024 · 08/29/2024

Class II: Risk

Recall Details

Recall Number
Z-3209-2024
Classification
Class II
Product Type
Device
Recalling Firm
Microcare Medical
Status
Ongoing
Date Initiated
08/29/2024
Location
Commerce City, CO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
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

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.