Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Good Vibrations

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Good Vibrationssee related information
Date Initiated by FirmAugust 29, 2024
Date PostedSeptember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3209-2024
Recall Event ID 95172
Product Classification Detergent - Product Code JCB
ProductGood 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
Code Information 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
Recalling Firm/
Manufacturer		 Microcare Medical
6120 E 58th Ave
Commerce City CO 80022-3971
For Additional Information ContactVenesia Hurtubise
959-225-5042 Ext. 296
Manufacturer 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
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 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.
Quantity in Commerce1649
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-