Events

Recall of Excelsior Medical Inc.

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
    74045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1989-2016
  • Event Initiated Date
    2016-04-28
  • Event Date Posted
    2016-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146056
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Reason
    Certain lots of heparin lock flush, usp syringes (5 ml fill in 10 ml syringe) failed anti-factor iia assay for potency during testing of retention samples for heparin potency.
  • Action
    Excelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.

Device

Excelsior Medical Inc.
  • Model / Serial
    Product Code, Lot number, Expiration date.  513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution.
  • Product Description
    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • Manufacturer Address
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753-4428
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA