Events

Recall of Device Recall Instructions for Use for Symphony Double Pumping Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medela 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
    54995
  • Event Risk Class
    Class 2
  • Event Number
    Z-1442-2010
  • Event Initiated Date
    2010-03-15
  • Event Date Posted
    2010-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89645
  • 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
    pump, breast, powered - Product Code HGX
  • Reason
    The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
  • Action
    An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.

Device

Device Recall Instructions for Use for Symphony Double Pumping Kit
  • Model / Serial
    item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: || a) Model 67023, Harmony to Symphony Conversion Kit; || b) Model 67091, Lactina to Symphony Conversion Retail Kit; || c) Model 67099, Symphony Retail Kit; || d) Model 67099-06, Symphony Retail Kit - case of 6 kits; || e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
  • Manufacturer
    Medela Inc

Manufacturer

Medela Inc
  • Manufacturer Address
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Manufacturer Parent Company (2017)
    Olle Larsson Holding Ag
  • Source
    USFDA