Events

Recall of Device Recall Alaris Medley LVP Frame Membrane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elite Biomedical Solutions 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
    71543
  • Event Risk Class
    Class 1
  • Event Number
    Z-2371-2015
  • Event Initiated Date
    2015-06-03
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138175
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
  • Action
    Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.

Device

Device Recall Alaris Medley LVP Frame Membrane
  • Model / Serial
    P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.
  • Product Description
    Alaris Medley LVP Frame Membrane. || Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
  • Manufacturer
    Elite Biomedical Solutions LLC

Manufacturer

Elite Biomedical Solutions LLC
  • Manufacturer Address
    Elite Biomedical Solutions LLC, 5150 Fordon Ct, Cincinnati OH 45244-5021
  • Manufacturer Parent Company (2017)
    Elite Biomedical Solutions Llc
  • Source
    USFDA