FDA recall Z-0930-2021

Braxton Medical Corporation · Class II · device

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 for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2020-09-04
Report date
2021-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lutz, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2021