Recall Z-3209-2024 ยท JCB Detergent
Microcare Medical
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
| Date | Sep 23, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Material/Component Contamination |
| Action | 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) |
| Quantity | 1649 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.