Medical device recalls Moderate risk

Braxton Medical Corporation recalls B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and…

Recall date
September 4, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0930-2021
FDA classification
Class II
Brand / firm
Braxton Medical Corporation
Sold / distributed
US Nationwide distribution including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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