Events

Recall of Device Recall 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synergetics 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
    67147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0884-2014
  • Event Initiated Date
    2013-12-09
  • Event Date Posted
    2014-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124952
  • 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
    Photocoagulator and accessories - Product Code HQB
  • Reason
    Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
  • Action
    Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.

Device

Device Recall 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc.
  • Model / Serial
    Lot numbers: M257130 and M265370
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
  • Product Description
    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
  • Manufacturer
    Synergetics Inc

Manufacturer

Synergetics Inc
  • Manufacturer Address
    Synergetics Inc, 3845 Corporate Centre Dr, O Fallon MO 63368-8678
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA