Events

Recall of THERA PEARL 3in1 BREAST THERAPY

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lansinoh Laboratories 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
    63390
  • Event Risk Class
    Class 2
  • Event Number
    Z-0784-2013
  • Event Initiated Date
    2012-08-14
  • Event Date Posted
    2013-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115101
  • 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
    Pack, hot or cold, reuseable - Product Code IME
  • Reason
    The spanish translation on the instructions for use (ifu) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
  • Action
    Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.

Device

THERA PEARL 3in1 BREAST THERAPY
  • Model / Serial
    Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
  • Product Description
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. || The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
  • Manufacturer
    Lansinoh Laboratories Inc

Manufacturer

Lansinoh Laboratories Inc
  • Manufacturer Address
    Lansinoh Laboratories Inc, 333 N Fairfax St Ste 400, Alexandria VA 22314-2632
  • Manufacturer Parent Company (2017)
    Pigeon Corp.
  • Source
    USFDA