Recall Z-1710-2019— Becton Dickinson & Company

Name: FDA recall Z-1710-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-01

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-03-01, terminated 2020-05-21. It names one FDA 510(k) clearance: K161777. Product: BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536. Reason: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-03-01
Terminated: 2020-05-21
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K161777 — BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc.·cleared 2016-08-29

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

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Reason for recall

Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

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