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
This recall is currently active, issued September 23, 2024. It was issued by Microcare Medical.
- Company
- Microcare Medical
- Recall Initiated
- August 29, 2024
- Posted
- September 23, 2024
- Recall Number
- Z-3209-2024
- Quantity
- 1649
- Firm Location
- Commerce City, CO
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Material/Component Contamination
Action Taken
On 8/29/24, recall notices were mailed to customers who were asked to do the following: 1) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. This recall should be carried out to the user level. 2) If your company repacked these medical devices into convenience kits or into other packaging, please contact your local FDA recall coordinator to evaluate the need for a new recall (https://www.fda.gov/safety/industry-guidance-recalls/ora-recallcoordinators). 3) Return partially-used or unused product to the recalling firm. 4) Complete and return the response form via email to qdc@microcare.com If you have any questions, contact the firm at 303-529-5937 or the email above.