Events

Recall of Device Recall Elcam

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

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
    76446
  • Event Risk Class
    Class 2
  • Event Number
    Z-1869-2017
  • Event Initiated Date
    2017-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154074
  • 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
    Stopcock, i.V. Set - Product Code FMG
  • Reason
    The stopcock was found to have punctures.
  • Action
    Elcam Medical sent their customers a recall letter/return response form dated February 2, 2017. Elcam is asking customers to examine their inventory for any affected products and to complete the return response form provided. For questions call 201-457-1120 ext. 102 or 201-457-1120 ext. 112.

Device

Device Recall Elcam
  • Model / Serial
    Lot #1670350901
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S Nationwide Distribution
  • Product Description
    Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls || Product Usage: || indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
  • Manufacturer
    Elcam Medical, Inc.

Manufacturer

Elcam Medical, Inc.
  • Manufacturer Address
    Elcam Medical, Inc., 2 University Plz Ste 620, Hackensack NJ 07601-6224
  • Manufacturer Parent Company (2017)
    Elcam Medical, Inc.
  • Source
    USFDA