Events

Recall of CLAMPLESS VALVED CATHETER CV-PICC INTRODUCER KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CATHETER INNOVATIONS.

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
    14422
  • Event Risk Class
    II
  • Event Initiated Date
    2001-12-14
  • 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
    Some units were shipped without the instructions for use and patient information guide because some packages were unsealed and the booklets slipped out of the pouches. sterility not affected.

Device

CLAMPLESS VALVED CATHETER CV-PICC INTRODUCER KIT
  • Model / Serial
    Model Catalog: PIC401CK (Lot serial: M001PIC602CKO M001PIC501CKO.); Model Catalog: PIC401CK (Lot serial: M001PIC502CKO M001PIC401CKO); Model Catalog: PIC501CK (Lot serial: M001PIC502CKO M001PIC401CKO); Model Catalog: PIC502CK (Lot serial: M001PIC502CKO M001PIC401CKO); Model Catalog: PIC601CK (Lot serial: M001PIC502CKO M001PIC401CKO); Model Catalog: PIC602CK (Lot serial: M001PIC502CKO M001PIC401CKO); Model Catalog: PIC501CK (Lot serial: M001PIC602CKO M001PIC501CKO.); Model Catalog: PIC502CK (Lot serial: M001PIC602CKO M001PIC501CKO.); Model Catalog: PIC601CK (Lot serial: M001PIC602CKO M001PIC501CKO.); Model Catalog: PIC602CK (Lot serial: M001PIC602CKO M001PIC501CKO.)
  • Product Description
    PASV PICC INSERTED CENTRAL CATHETERS
  • Manufacturer
    CATHETER INNOVATIONS

Manufacturer

CATHETER INNOVATIONS
  • Manufacturer Address
    SALT LAKE CITY
  • Source
    HC