Events

Recall of Device Recall Otocell Ear Wick

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Medical Products, 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
    25435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-03
  • Event Initiated Date
    2003-01-22
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25829
  • 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
  • Reason
    Product sterility may be compromised.
  • Action
    Boston Medical Products notified their accounts by letter on 1/22/03. Users are requested to discard product and complete reply form.

Device

Device Recall Otocell Ear Wick
  • Model / Serial
    Lot Number: 56003 Exp.Date: 7/2005
  • Distribution
    Nationwide
  • Product Description
    Boston Medical Products Otocell Ear Wick 15 mm, sterile || Ref: EW-0915
  • Manufacturer
    Boston Medical Products, Inc.

Manufacturer

Boston Medical Products, Inc.
  • Manufacturer Address
    Boston Medical Products, Inc., 117 Flanders Rd, Westborough MA 01581-1042
  • Source
    USFDA