# FDA recall Z-1279-2025

> **Smiths Medical ASD, Inc.** · Class I · device recall initiated 2025-02-13.

## Product

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

## Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1279-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-13
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2025

## Citation

> AI Analytics. FDA recall Z-1279-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1279-2025. Source: US FDA. Licensed CC0.

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