Recall of Device Recall Large Bore Central Venous Catheters

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Central Venous Catheters - Product Code FOZ
  • Reason
    Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
  • Action
    The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.


  • Model / Serial
    Product numbers AK-15123-H - Lot numbers: RF8020142, RF8029122, RF8031799, RF8045050, RF8084251, RF8123397, RF9027126, and RF9039409; Product numbers AK-15123-J - Lot numbers: RF8031856, RF8056908, and RF8071778; Product numbers CS-15123-E - Lot numbers: RF8044326, RF8071238, RF8097152, RF9014658, RFZF8027313, ZF8027652, ZF8037872, ZF8048327, ZF8058745, ZF8069575, ZF8070317, ZF8079993, ZF8080559, ZF8091380, ZF8113337, ZF8123891, ZF9014736, ZF9014737, ZF9014797, ZF9025529, ZF9035668; and Product numbers MC-15123 - Lot numbers: RF8044327, RF8069574, RF8084830, RF9016649, and RF9039995.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
  • Product Description
    12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. || The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
  • Manufacturer


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