Events

Recall of Reinforced Dual Lumen Cannula, 28Fr

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OriGen Biomedical, 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
    78033
  • Event Risk Class
    Class 1
  • Event Number
    Z-0021-2018
  • Event Initiated Date
    2017-08-02
  • 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=158533
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Two users have reported to origen that a vv28f origen reinforced dual lumen ecmo catheter has had a separation of the clear extension tube from the hub connection. these adverse events resulted in patient injury (blood loss).
  • Action
    The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.

Device

Reinforced Dual Lumen Cannula, 28Fr
  • Model / Serial
    Lot Numbers: N18487, N18487-1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
  • Product Description
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
  • Manufacturer
    OriGen Biomedical, Inc.

Manufacturer

OriGen Biomedical, Inc.
  • Manufacturer Address
    OriGen Biomedical, Inc., 7000 Burleson Rd Bldg D, Austin TX 78744-3202
  • Manufacturer Parent Company (2017)
    Origen Biomedical Inc.
  • Source
    USFDA