Events

Recall of Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain

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
    59453
  • Event Risk Class
    Class 2
  • Event Number
    Z-3172-2011
  • Event Initiated Date
    2011-07-27
  • Event Date Posted
    2011-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102825
  • 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
    Wound Dressing Kit - Product Code MCY
  • Reason
    Medela determined that some of the individual kits or bags of lot #370118 of "0877061 wound dressing set, tier i, 10 mm flat drain", were labeled incorrectly as "0877067 wound dressing set, tier iii 15 fr round channel drain". the outside label on the case is correctly labeled as "0877061 wound dressing set, tier 1,10 mm flat drain".
  • Action
    Medela Inc. sent an "Urgent Device Recall" letter dated July 26, 2011 to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.

Device

Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain
  • Model / Serial
    product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
  • Product Description
    Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. || Medela Healthcare, || McHenry, IL 60051; || A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; || Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
  • 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