---
title: "smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... — FDA record Z-1281-2025 | Is It on Recall"
description: "The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect."
url: https://isitonrecall.com/recall/fda-device-z-1281-2025-smiths-medical-proport-plastic-venous-access-system-polyflow-polyurethane-catheter-2-6mm-o-d-7-8fr-x/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D.,... — FDA record Z-1281-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
- **Reason**: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- **Classification**: Class I
- **Recalling firm**: Smiths Medical ASD, Inc.
- **Quantity**: 3263 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1281-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1281-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 26, 2025
- **Recall initiation date**: Feb 13, 2025
- **Center classification date**: Mar 18, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1281-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical ASD Inc. records](https://isitonrecall.com/brand/smiths-medical-asd-inc/)