Events

Recall of Continuous Peropheral Nerve Block Catheter Kit and Set

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
    66589
  • Event Risk Class
    Class 2
  • Event Number
    Z-0546-2014
  • Event Initiated Date
    2013-10-09
  • Event Date Posted
    2013-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122660
  • 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
    A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
  • Action
    The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.

Device

Continuous Peropheral Nerve Block Catheter Kit and Set
  • Model / Serial
    Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
  • Product Description
    Continuous Peripheral Nerve Block Catheter Kit and Set || Continuous Peripheral Nerve Block Catheter Kit and Set 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