Events

Recall of Device Recall DeVilbiss 7305PD Suction Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeVilbiss Healthcare LLC.

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
    74308
  • Event Risk Class
    Class 2
  • Event Number
    Z-2246-2016
  • Event Initiated Date
    2016-05-23
  • Event Date Posted
    2016-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147116
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Reason
    A small percentage of units of 7305 series vacu-aide suction units are experiencing premature failure during operation.
  • Action
    DeVilbiss Healthcare sent an Urgent - Medical Device Recall letter on May 23, 2016, to all affected customers notifying them of the issue. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to isolate all of the affected units included on the serial number list and return for replacement. For further questions, please call (814) 443-7602.

Device

Device Recall DeVilbiss 7305PD Suction Unit
  • Model / Serial
    Serial numbers: PD465146 - PD465193
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
  • Product Description
    DeVilbiss Model 7305P-D Powered Suction Unit
  • Manufacturer
    DeVilbiss Healthcare LLC

Manufacturer

DeVilbiss Healthcare LLC
  • Manufacturer Address
    DeVilbiss Healthcare LLC, 100 Devilbiss Dr, Somerset PA 15501-2125
  • Manufacturer Parent Company (2017)
    Medical Depot Inc.
  • Source
    USFDA