Events

Recall of EMPIRA RX PTCA DILATION CATHETERS - 12.0MM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    28369
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-24
  • 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
    Following a small number of complaints regarding balloon cover removal difficulty when preparing the affected products for use a customer communication letter has been issued with reminders and additional information relative to the labeling of the empira nc rx and empira rx ptca products.

Device

EMPIRA RX PTCA DILATION CATHETERS - 12.0MM
  • Model / Serial
    Model Catalog: 85R12350S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12400S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12375S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12150S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12325S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12300S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12275S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12250S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12225S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 85R12200S (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 75R25200N (Lot serial: CE0000417); Model Catalog: 75R25375N (Lot serial: CE0000402); Model Catalog: 75R25350N (Lot serial: CE0000402); Model Catalog: 75R25325N (Lot serial: CE0000402); Model Catalog: 75R25275N (Lot serial: CE0000402); Model Catalog: 75R25250N (Lot serial: CE0000402); Model Catalog: 75R25225N (Lot serial: CE0000402); Model Catalog: 85R06375
  • Product Description
    EMPIRA RX PTCA DILATATION CATHETER 12MM
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.