# FDA recall Z-2458-2024

> **Becton Dickinson Infusion Therapy Systems, Inc.** · Class II · device recall initiated 2024-06-26.

## Product

BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.

## Reason for recall

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

## Distribution

US: IL OUS: N/A0

## Key facts

- **Recall number:** Z-2458-2024
- **Recalling firm:** Becton Dickinson Infusion Therapy Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-26
- **Report date:** 2024-08-07

- **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-2458-2024

## Citation

> AI Analytics. FDA recall Z-2458-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2458-2024. Source: US FDA. Licensed CC0.

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