# FDA recall Z-1908-2018

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-04-25.

## Product

Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173    Product Usage:  Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

## Reason for recall

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling.  The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

## Distribution

Worldwide Distribution - US Distribution

## Key facts

- **Recall number:** Z-1908-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-25
- **Report date:** 2018-05-30
- **Termination date:** 2020-12-16

- **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-1908-2018

## Citation

> AI Analytics. FDA recall Z-1908-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1908-2018. Source: US FDA. Licensed CC0.

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