Recall of GROSHONG PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAYS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD 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
    100419
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-15
  • Event Country
  • 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
    Bard access systems is informing customers of an incorrect expiration date on product labeling for specific lots of hickman and leonard central venous catheter kits. the expiration date for the needle provided in these specific kits was not reflected in the unit or case product labeling. product return is not required.

Device

  • Model / Serial
    Model Catalog: 0600630 (Lot serial: HUZL0688); Model Catalog: 0600630 (Lot serial: HUZD1465); Model Catalog: 0600630 (Lot serial: HUZC1074); Model Catalog: 0600630 (Lot serial: HUYL1323); Model Catalog: 0600630 (Lot serial: HUZB0323); Model Catalog: 0600630 (Lot serial: HUZA0513); Model Catalog: 0600630 (Lot serial: HUZB1191); Model Catalog: 0606560 (Lot serial: HUZA0561); Model Catalog: 0600600 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 0600620 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 0600650 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 0600560 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    LEONARD CENTRAL VENOUS CATHETER;HICKMAN 10FR TRIPLE LUMEN CV CATHETER;HICKMAN CENTRAL VENOUS CATHETERS
  • Manufacturer

Manufacturer