Events

Recall of Device Recall Negative Pressure Wound Therapy Powered Suction Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accuro Medical Product 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
    63064
  • Event Risk Class
    Class 2
  • Event Number
    Z-0009-2013
  • Event Initiated Date
    2012-08-31
  • Event Date Posted
    2012-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112429
  • 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 Pro Apex Negative Pressure Wound Therapy - Product Code OMP
  • Reason
    Accuro has received reports of some apex pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
  • Action
    The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.

Device

Device Recall Negative Pressure Wound Therapy Powered Suction Pump
  • Model / Serial
    part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Product Description
    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 || Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
  • Manufacturer
    Accuro Medical Product LLC

Manufacturer

Accuro Medical Product LLC
  • Manufacturer Address
    Accuro Medical Product LLC, 2854 Hitchcock Ave, Downers Grove IL 60515-4016
  • Manufacturer Parent Company (2017)
    Accuro Medical Products Llc
  • Source
    USFDA