Events

Recall of Device Recall Halo Closed System Transfer Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by J&J; Solutions, Inc. DBA Corvida Medical.

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
    75810
  • Event Risk Class
    Class 2
  • Event Number
    Z-1003-2017
  • Event Initiated Date
    2016-11-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151346
  • 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
    Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
  • Reason
    Product malfunction: needle does not retract.
  • Action
    Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.

Device

Device Recall Halo Closed System Transfer Device
  • Model / Serial
    Lot 0610525, 2017-10-18
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
  • Product Description
    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
  • Manufacturer
    J&J; Solutions, Inc. DBA Corvida Medical

Manufacturer

J&J; Solutions, Inc. DBA Corvida Medical
  • Manufacturer Address
    J&J; Solutions, Inc. DBA Corvida Medical, 2261 Crosspark Rd Ste 127, Coralville IA 52241-4716
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA