Events

Recall of Device Recall Arrow ASK20608CMC StimuCath Continuous Nerve Block Kit

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
    59113
  • Event Risk Class
    Class 2
  • Event Number
    Z-2894-2011
  • Event Initiated Date
    2011-06-17
  • Event Date Posted
    2011-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101243
  • 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
    Some of the outer trays used in the packaging were found to have an insufficient seal. therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.
  • Action
    Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.

Device

Device Recall Arrow ASK20608CMC StimuCath Continuous Nerve Block Kit
  • Model / Serial
    Lot # MF0126544
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the state of North Carolina.
  • Product Description
    Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. || Arrow International, Inc. || Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
  • 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