---
title: "smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF... — FDA record Z-0147-2025 | Is It on Recall"
description: "Uncertainty in the seal integrity of the sterile packaging."
url: https://isitonrecall.com/recall/fda-device-z-0147-2025-smiths-medical-portex-thermovent-1200-15mm-22mm-a-ref-100-582-000-b-ref-100-582-000jp-c-ref-100-582/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS — FDA record Z-0147-2025

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 Jul 18, 2024. 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 portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
- **Reason**: Uncertainty in the seal integrity of the sterile packaging.
- **Classification**: Class II
- **Recalling firm**: Smiths Medical ASD Inc.
- **Quantity**: 141,196 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0147-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0147-2025%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 | a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057 |

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**: Oct 30, 2024
- **Recall initiation date**: Jul 18, 2024
- **Center classification date**: Oct 23, 2024

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-0147-2025%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/)