Events

Recall of Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC).

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

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
    26213
  • Event Risk Class
    Class 2
  • Event Number
    Z-0849-03
  • Event Initiated Date
    2003-04-09
  • Event Date Posted
    2003-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27275
  • 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, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Nutriline with peelable sheath 2 fr. and neonatal catheter & insertion tray were packaged with a 3 fr. insertion sheath.
  • Action
    Recalls letters were sent out to customers and sales representatives on 4/9/2003. They were also notified via e-mails and phone calls on 4/9/2003.

Device

Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC).
  • Model / Serial
    Lot #B01A48 Exp. 11/2007
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
  • Product Description
    Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Sterilization occurs via EtO in Germany.
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation
  • Manufacturer Address
    Vygon Corporation, 1 Madison Street, East Rutherford NJ 07073
  • Source
    USFDA