Events

Recall of Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH

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
    60314
  • Event Risk Class
    Class 2
  • Event Number
    Z-0309-2012
  • Event Initiated Date
    2011-06-20
  • Event Date Posted
    2011-11-30
  • 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=105014
  • 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 of the ask-19608-sfh continuous nerve block kits, lot # mf0127039 were found to have an insufficient seal. therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.
  • Action
    The firm, Arrow International, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account. If you have questions or concerns, please call this toll free number 800-233-3187.

Device

Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH
  • Model / Serial
    Lot number MF0127039
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CT
  • Product Description
    Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 || Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of 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