Events

Recall of Device Recall NeatNick

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hawaii Medical LLC.

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
    37984
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-2007
  • Event Initiated Date
    2007-05-11
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52627
  • 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
    Heel Lancet - Product Code FMK
  • Reason
    Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient.
  • Action
    Hawaii Medical notified the initial distributor and end users by telephone and follow-up Recall Notification Letter on May 15, 2007.

Device

Device Recall NeatNick
  • Model / Serial
    Lot Number: M095007, M066008
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    NeatNick Sweeping Action Heel Lancet - Preemie- || Item Number: 1030083 (box of 100) and || Item Number: 1030084, case of 1,000 (10 boxes of 100)
  • Manufacturer
    Hawaii Medical LLC

Manufacturer

Hawaii Medical LLC
  • Manufacturer Address
    Hawaii Medical LLC, 750 Corporate Park, Pembroke MA 02359
  • Source
    USFDA