Events

Recall of Device Recall ARROW Epidural Needle Component

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
    70177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1080-2015
  • Event Initiated Date
    2015-01-05
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132410
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Reason
    The product labeling does not specify the 5 year shelf life of the product.
  • Action
    Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product.

Device

Device Recall ARROW Epidural Needle Component
  • Model / Serial
    Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide, Canada and Mexico.
  • Product Description
    ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
  • Manufacturer
    Arrow International Inc

Manufacturer

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