Events

Recall of Device Recall Durex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Reckitt Benckiser 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
    75829
  • Event Risk Class
    Class 2
  • Event Number
    Z-1249-2017
  • Event Initiated Date
    2016-11-22
  • 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=151432
  • 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
    Condom - Product Code HIS
  • Reason
    Reckitt benckiser llc is recalling durex condoms pleasure packs due to missing information on the package labeling associated with the active ingredient benzocaine.
  • Action
    Reckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns.

Device

Device Recall Durex
  • Model / Serial
    3ct - item code 02340-30042-04  lot code exp date   3 ct - Walmart item code 02340-70042-04  lot code exp date   12ct - item code 02340-30274-08  lot code exp date   24 ct - item code 02340-302190-04  lot codes and exp date
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign
  • Product Description
    Durex Pleasure Pack . || 3 ultra fine lubricated latex condoms || 12 ultra fine lubricated latex condoms || 24 Ra fine lubricated latex condoms || 3 ct UPC 3-02340-30042-04-1 || 3 ct - Walmart UPC 02340-70042-04 || 12ct - UPC 3-02340-30274-08-6 || 24 ct - UPC 302340-302190-04 || (contacting firm for label)
  • Manufacturer
    Reckitt Benckiser LLC

Manufacturer

Reckitt Benckiser LLC
  • Manufacturer Address
    Reckitt Benckiser LLC, 399 Interpace Pkwy, Parsippany NJ 07054-1133
  • Manufacturer Parent Company (2017)
    Reckitt Benckiser Group Plc
  • Source
    USFDA