Events

Recall of MEDLINE Sterile Needle Counter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    80017
  • Event Risk Class
    Class 2
  • Event Number
    Z-1934-2018
  • Event Initiated Date
    2018-04-24
  • 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=164220
  • 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
    Needle, suturing, disposable - Product Code GAB
  • Reason
    The product packaging seal has the potential to experience seal creep. this may result in gaps to be created in the seals of the packaging and may impact the sterility of the needle counters.
  • Action
    Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704.

Device

MEDLINE Sterile Needle Counter
  • Model / Serial
    Lot Numbers: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
  • Product Description
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR || Product Usage: || A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, Three Lakes Drive, Northfield IL 60093
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA