# FDA recall Z-3085-2024

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2024-08-20.

## Product

Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

## Reason for recall

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-3085-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-20
- **Report date:** 2024-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3085-2024

## Citation

> AI Analytics. FDA recall Z-3085-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3085-2024. Source: US FDA. Licensed CC0.

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