Events

Recall of Arrow VPS Access 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
    77163
  • Event Risk Class
    Class 2
  • Event Number
    Z-2170-2017
  • Event Initiated Date
    2017-04-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155122
  • 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
    Catheter, ultrasound, intravascular - Product Code OBJ
  • Reason
    Arrow international is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3m tegaderm chg chlorhexidine gluconate i.V. securement dressing.
  • Action
    Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131.

Device

Arrow VPS Access Kit
  • Model / Serial
    ASK-04001-DU9 and ASK-04001-DU10 Device Listing Number D156491 Lot Numbers: 23F15L0593 23F16A0300 23F16B0028 23F16B0523 23F16J0151 23F16K0363 23F16K0431 23F16K0820 23F15L0662 23F16A0298 23F16B0338 23F16C0321 23F16C0632 23F16J0105 23F16K0449
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : NC
  • Product Description
    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
  • 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