---
title: "AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... — FDA record Z-0360-2024 | Is It on Recall"
description: "Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos"
url: https://isitonrecall.com/recall/fda-device-z-0360-2024-avanos-ballard-closed-suction-system-for-adults-14-fr-dse-mdi-product-code-221038-provide-suction-on/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on... — FDA record Z-0360-2024

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 Oct 13, 2023. 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**: AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
- **Reason**: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
- **Classification**: Class II
- **Recalling firm**: Avanos Medical, Inc.
- **Quantity**: 4730 cases (94600 devices)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0360-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0360-2024%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 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991 |

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

## Distribution

US and South Africa

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

## Dates in the source

- **Report date**: Nov 29, 2023
- **Recall initiation date**: Oct 13, 2023
- **Center classification date**: Nov 20, 2023

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-0360-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Avanos Medical, Inc. records](https://isitonrecall.com/brand/avanos-medical-inc/)