Events

Recall of Device Recall Excelsior Medical

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

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
    68573
  • Event Risk Class
    Class 2
  • Event Number
    Z-2070-2014
  • Event Initiated Date
    2014-06-05
  • Event Date Posted
    2014-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128242
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Reason
    There is a potential for a leak. a molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
  • Action
    Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that it was supplied to and notify them at once of the product recall. A phone number was provided in case customers had questions regarding the recall (1.800.487.4276 8:30 am - 5:00 pm EST) as well as an email address (recall12@excelsiormedical.com).

Device

Device Recall Excelsior Medical
  • Model / Serial
    Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213  Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Manufacturer Address
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA