Events

Recall of ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.

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
    34961
  • Event Risk Class
    Class 2
  • Event Number
    Z-0870-06
  • Event Initiated Date
    2006-03-21
  • Event Date Posted
    2006-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45021
  • 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
    Infusion pump - Product Code FRN
  • Reason
    Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. the esp pump works correctly when used in 60 mode with a 60cc syringe or smaller.
  • Action
    An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.

Device

ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excels...
  • Model / Serial
    All Serial Numbers since 1996.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Quebec, Canada
  • Product Description
    ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Manufacturer Address
    Excelsior Medical Corp, 1923 Heck Ave, Neptune NJ 07753-4428
  • Source
    USFDA