Events

Recall of Device Recall NiceEnSmooth Berry Burst

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Altasource LLC dba Meta Labs LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67976
  • Event Risk Class
    Class 2
  • Event Number
    Z-1500-2014
  • Event Initiated Date
    2014-02-03
  • Event Date Posted
    2014-04-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126717
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nice-En-Smooth Berry Burst - Product Code NA
  • Reason
    Firm is not registered as a drug manufacturer.
  • Action
    Meta Labs notified customers of the Voluntary Recall Notification letter on February 4, 2014. The letter requested that the products be returned. For questions call 770-645-0602.

Device

Device Recall NiceEnSmooth Berry Burst
  • Model / Serial
    Lot 8-94034
  • Distribution
    USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.
  • Product Description
    Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 || Product Usage: || Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
  • Manufacturer
    Altasource LLC dba Meta Labs LLC

Manufacturer

Altasource LLC dba Meta Labs LLC
  • Manufacturer Address
    Altasource LLC dba Meta Labs LLC, 1009 Mansell Rd Ste J, Roswell GA 30076-4806
  • Manufacturer Parent Company (2017)
    Meta Labs Inc
  • Source
    USFDA