Events

Recall of Device Recall KY SilkE Vaginal Moisturizer and Personal Lubricant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mc-NEIL-PPC, Inc..

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
    64322
  • Event Risk Class
    Class 2
  • Event Number
    Z-0874-2013
  • Event Initiated Date
    2013-01-25
  • Event Date Posted
    2013-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115831
  • 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
    Lubricant, personal - Product Code NUC
  • Reason
    This product is not cleared for marketing in the us.
  • Action
    Johnson and Johnson Healthcare Products sent recall notification letters dated 1/25/2013 to its customers (retailers and wholesalers). The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to return all cases of affected product in their possession. The letter included delivery confirmation and a return packing slip, return authorization label and business reply card. Contact J & J Sales & Logistics at 866-912-8414 for questions regarding the return of affected product. Contact your J & J Sales & Logistics Company Sales Representative for questions about the product.

Device

Device Recall KY SilkE Vaginal Moisturizer and Personal Lubricant
  • Model / Serial
    Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
  • Manufacturer
    Mc-NEIL-PPC, Inc.

Manufacturer

Mc-NEIL-PPC, Inc.
  • Manufacturer Address
    Mc-NEIL-PPC, Inc., 199 Grandview Rd, Skillman NJ 08558-1311
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA