# FDA recall Z-0930-2021

> **Braxton Medical Corporation** · Class II · device recall initiated 2020-09-04.

## 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

- **Recall number:** Z-0930-2021
- **Recalling firm:** Braxton Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-04
- **Report date:** 2021-02-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lutz, FL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0930-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0930-2021. Source: US FDA. Licensed CC0.

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