Events

Recall of NEEDLE FREE DISPENSING PINS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by B. BRAUN MEDICAL 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
    25191
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-11
  • 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
    Bbmi has recently identified a potential for a tear in the outer blister packaging of a limited number of non-vented dispensing pins/transfer spikes. the tears have been identified in the blister package paper where the unit label writing is located.

Device

NEEDLE FREE DISPENSING PINS
  • Model / Serial
    Model Catalog: 412027 (Lot serial: >10 CONTACT MFG); Model Catalog: 412023 (Lot serial: >10 CONTACT MFG); Model Catalog: 412027 (Lot serial: > 10 numbers contact mfg); Model Catalog: 412023 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    NEEDLE FREE DISPENSING PINS;NON-VENTED DISPENSING PIN
  • Manufacturer
    B. BRAUN MEDICAL INC.

Manufacturer

B. BRAUN MEDICAL INC.