Events

Recall of 9x15" Medium Utility Positioner with Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Molnlycke Health Care, 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
    78058
  • Event Risk Class
    Class 2
  • Event Number
    Z-0417-2018
  • Event Initiated Date
    2017-07-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160821
  • 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
    Infant Positioner, Rx, Use In Highly Monitored Setting - Product Code OUW
  • Reason
    Products may not meet specifications due to possible presence of metal shavings.
  • Action
    Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.

Device

9x15" Medium Utility Positioner with Cover
  • Model / Serial
    Recorder Code 1400239
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
  • Product Description
    9x15" Medium Utility Positioner with Cover
  • Manufacturer
    Molnlycke Health Care, Inc

Manufacturer

Molnlycke Health Care, Inc
  • Manufacturer Address
    Molnlycke Health Care, Inc, 5550 Peachtree Pkwy Ste 500, Norcross GA 30092-2555
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    USFDA