Events

Recall of Device Recall Epidural Needle

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
    29463
  • Event Risk Class
    Class 3
  • Event Number
    Z-1300-04
  • Event Initiated Date
    2004-06-07
  • Event Date Posted
    2004-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33792
  • 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 recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
  • Action
    The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.

Device

Device Recall Epidural Needle
  • Model / Serial
    Lot No. RF4044686, expiration date 2006-09
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
  • Product Description
    ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
  • 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