Recall Z-0930-2021— Braxton Medical Corporation

Name: FDA recall Z-0930-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-04

Class II · Ongoing

Class II FDA medical device recall by Braxton Medical Corporation, initiated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.. Reason: Recalled products do not have FDA approval for sale in the United States..

Recalling firm: Braxton Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-09-04
Firm location: Lutz, FL, United States

Product description

B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

Reason for recall

Recalled products do not have FDA approval for sale in the United States.

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