Events

Recall of ETHICON

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    74901
  • Event Risk Class
    Class 2
  • Event Number
    Z-2889-2016
  • Event Initiated Date
    2016-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148716
  • 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
    Instrument, surgical, disposable - Product Code KDC
  • Reason
    Ethicon mersilene" tape (also referred to as mersilenetm polyester fiber strip or mersilenetm fiber ligature) products are being recalled since a group of mersilene" tape product codes are being supplied with an incorrect instructions for use (ifu) insert.
  • Action
    Ethicon Inc. sent an Urgent - Medical Device Correction Notification dated August 1, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this correction on hand and locate such product(s). Refer to Attachment 2 for the Product Identification Tool to identify the products that are subject to this correction by using package labels. 2. Please read Attachment 1 included within this letter thoroughly - MERSILENE" Tape Instructions for Use (IFU). 3. Ensure all users are aware of the issue by distributing this notice to all users of the Ethicon MERSILENE" Tape devices in your facility. 4. Replace the existing incorrect MERSILENE" Suture Instructions for Use (IFU) with the MERSILENE"Tape Instructions for Use (IFU) provided in Attachment 1 and dispose of the incorrect MERSILENE" Suture Instructions for Use (IFU) per your internal procedures. 5. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 1- (866) 723-2836 or Ethicon8698@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this correction. 6. Keep this notice visibly posted with product subject to this correction in your facility for awareness. For further questions, please call (908) 218-0707.

Device

ETHICON
  • Model / Serial
    All unexpired lots   MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
  • Product Description
    ETHICON MERSILENE" Tape || (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA