Becton Dickinson Nexiva Closed IV Catheter System and Nexiva Diffusics Closed IV Catheter System (2014-02-14)

Starting date:

February 14, 2014

Posting date:

April 22, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-39169

• 
  Reason
• 
  Affected products

Recalled Products

A. Becton Dickinson Nexiva Closed IV Catheter System with Q-Syte Adapter

B. Becton Dickinson Nexiva Closed IV Catheter System - Single Port

C. Becton Dickinson Nexiva Diffusics Closed IV Catheter System

Reason

Leaking Septa have been observed in manufacturing and also in customer complaints. Health Canada requested on December 16, 2013, that "all users of the product" be notified of the situation, an "informal notification", a "level ill recall". Date problem was first identified: April 30, 2012. How the problem was identified: During routine, in-process leak inspection of product during manufacture. Customer complaints: Observed increased complaint rate for leakage during April - June 2012

Affected products