Events

Recall of Device Recall LIS27T Lacrimal Intubation Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quest Medical, 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
    70633
  • Event Risk Class
    Class 2
  • Event Number
    Z-1368-2015
  • Event Initiated Date
    2015-02-26
  • Event Date Posted
    2015-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134177
  • 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
    Probe, lachrymal - Product Code HNL
  • Reason
    Expiration date incorrectly printed in manufacturing date field on both pouch and carton labels.
  • Action
    The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.

Device

Device Recall LIS27T Lacrimal Intubation Set
  • Model / Serial
    Lot 40905AQ and 40601C
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.
  • Product Description
    LIS27T - Lacrimal Intubation Set RX Only Sterile || Used in various ophthalmology procedures.
  • Manufacturer
    Quest Medical, Inc.

Manufacturer

Quest Medical, Inc.
  • Manufacturer Address
    Quest Medical, Inc., 1 Allentown Pkwy, Allen TX 75002-4206
  • Manufacturer Parent Company (2017)
    Quest Medical Inc.
  • Source
    USFDA