Recall Z-1440-2022— Becton Dickinson & Company

Name: FDA recall Z-1440-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-09

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2022-05-09. It names one FDA 510(k) clearance: K974083. Product: Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS). Reason: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Ongoing
Initiated: 2022-05-09
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K974083 — CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSOhmeda Medical·cleared 1998-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)

Reason for recall

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Data sourced from openFDA. This site is unofficial and independent of the FDA.