Events

Recall of Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Blade

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Summit 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
    65034
  • Event Risk Class
    Class 2
  • Event Number
    Z-1319-2013
  • Event Initiated Date
    2013-03-27
  • Event Date Posted
    2013-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117723
  • 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
    Ear Knives - Product Code JYO
  • Reason
    Summit medical has initiated a recall of myringotomy lance blade (juvenile) because the box contains the wrong blade. the box contains myringotomy spear blade (juvenile).
  • Action
    Summit Medical sent a Medical Device Recall letter dated March 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately examine your inventory, and quarantine the product subject to this recall. Please complete and return the enclosed "Recall Response Form" as soon as possible. The fax number is (651) 789-3961. For further questions please call (651) 789-3921.

Device

Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Blade
  • Model / Serial
    Lot No. 121012
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in MS, NY, PA and TX.
  • Product Description
    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 || Use to make an incision in the tympanic membrane.
  • Manufacturer
    Summit Medical, Inc.

Manufacturer

Summit Medical, Inc.
  • Manufacturer Address
    Summit Medical, Inc., 815 Northwest Pkwy Ste 100, Eagan MN 55121-1658
  • Source
    USFDA