Events

Recall of Device Recall ARROW PICC powered by ARROW VPS Stylet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International 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
    78964
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2018
  • Event Initiated Date
    2017-07-25
  • 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=160975
  • 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
    Peripherally Inserted Central Catheter - Product Code LJS
  • Reason
    Finished good kits may contain incorrect components. kits that should contain a 5 fr 2 lumen catheter may contain a 4 fr single lumen catheter and kits that should contain a 4 fr single lumen catheter may contain a 5 fr 2 lumen catheter. this may cause a delay in treatment while a replacement catheter is obtained.
  • Action
    Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.

Device

Device Recall ARROW PICC powered by ARROW VPS Stylet
  • Model / Serial
    Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA