# FDA recall Z-0400-2024

> **Becton Dickinson Infusion Therapy Systems Inc.** · Class II · device recall initiated 2023-10-04.

## Product

BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

## Reason for recall

Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

## Distribution

US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.

## Key facts

- **Recall number:** Z-0400-2024
- **Recalling firm:** Becton Dickinson Infusion Therapy Systems Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-04
- **Report date:** 2023-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sandy, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2024

## Citation

> AI Analytics. FDA recall Z-0400-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0400-2024. Source: US FDA. Licensed CC0.

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