Events

Recall of ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA 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
    46302
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Arrow international is recalling this product because the packaging may not be completely sealed. if the packaging is compromised in this manner the sterility of the product cannot be guaranteed. if a non-sterile product is used there is potential for infection to occur.

Device

ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
  • Model / Serial
    Model Catalog: ASK-15703-PRJ (Lot serial: 13F17D0112); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17D0112); Model Catalog: CDA-21242-1A (Lot serial: 13F17F0437); Model Catalog: CDA 42802-P1A (Lot serial: 13F17D0039); Model Catalog: CA-42703-P1A (Lot serial: 13F17D0039); Model Catalog: CDA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA 42802-P1A (Lot serial: 13F17C0266); Model Catalog: CA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-42703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA 42802-P1A (Lot serial: 13F17A0301); Model Catalog: CA-42703-P1A (Lot seria
  • Product Description
    PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH;ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;ERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH INTEGRAL HEMOSTASIS VALVE/
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.