Microcare Medical: Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1,

Hazard

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

Details from the source

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. Quantity: 1649 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

UPC codes

723754044532

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.