Events

Recall of Universal Pumping Kit (Sterile)

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
    56498
  • Event Risk Class
    Class 2
  • Event Number
    Z-2485-2010
  • Event Initiated Date
    2010-08-06
  • Event Date Posted
    2010-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93795
  • 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 product sterility may be compromised due to possible pinholes in the rigid tray of the package.
  • Action
    Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amount of product being returned. Distributors were requested to notify their customers. Questions about the recall process may be directed to Stericycle at 1-877-247-9970. Information on the recall is posted on Medela's website www.medelabreastfeedingus.com

Device

Universal Pumping Kit (Sterile)
  • Model / Serial
    article #67093S, al lot numbers
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda.
  • Product Description
    Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67093S
  • 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