Events

Recall of Device Recall GelE Donut, Squishon 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Childrens Medical Ventures.

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
    68443
  • Event Risk Class
    Class 1
  • Event Number
    Z-2192-2014
  • Event Initiated Date
    2014-05-28
  • Event Date Posted
    2014-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127715
  • 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
    Protector, skin pressure - Product Code FMP
  • Reason
    The gel-filled gel-e donut and squishon product line has received a number of complaints about visible mold. the mold detected was determined to be cladosporium and penicillium fungi, which are commonly found molds.
  • Action
    Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:

Device

Device Recall GelE Donut, Squishon 2
  • Model / Serial
    All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the country of Canada.
  • Product Description
    Gel-E Donut, Squishon 2 gel pillows || Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • Manufacturer Address
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA