Events

Recall of Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits

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
    76637
  • Event Risk Class
    Class 2
  • Event Number
    Z-1705-2017
  • Event Initiated Date
    2017-03-03
  • Event Date Posted
    2017-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153712
  • 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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Reason
    Arrow international, inc. notified its customers who received the affected antimicrobial/antithrombogenic picc kits, that the kits were being recalled due to a labeling error. the lidstock on some of the kits reads cdc-45541-hpk1a, while the banner card on the side of the kit reads cdc-45052-hpk1a. other kits may list cdc-45052-hpk1a on the lidstock and cdc-45541-hpk1a on the banner card. the affected lot numbers are 23f16c0851, 23f16a0727, and 23f16c0844.
  • Action
    Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.

Device

Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits
  • Model / Serial
    Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution
  • Product Description
    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
  • 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