# FDA recall Z-1102-2021

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2020-12-21.

## Product

Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.

## Reason for recall

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.

## Key facts

- **Recall number:** Z-1102-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-21
- **Report date:** 2021-02-17
- **Termination date:** 2024-07-11

- **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-1102-2021

## Citation

> AI Analytics. FDA recall Z-1102-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1102-2021. Source: US FDA. Licensed CC0.

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