# FDA recall Z-1653-2022

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2022-08-09.

## Product

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403.  An in-line injection site.

## Reason for recall

Firm noted an increase in customer reports of leaks.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1653-2022
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-08-09
- **Report date:** 2022-09-21
- **Termination date:** 2024-08-09

- **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-1653-2022

## Citation

> AI Analytics. FDA recall Z-1653-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1653-2022. Source: US FDA. Licensed CC0.

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