# FDA recall Z-0561-2024

> **MEDLINE INDUSTRIES, LP - Northfield** · Class I · device recall initiated 2023-10-16.

## Product

Tracheostomy care kits:    (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile;    (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile;    (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile;    (4) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile;    (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and    (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.

## Reason for recall

The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury.  Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.

## Distribution

US Nationwide distribution including Puerto Rico.    OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0561-2024
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-16
- **Report date:** 2024-01-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2024

## Citation

> AI Analytics. FDA recall Z-0561-2024. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0561-2024. Source: US FDA. Licensed CC0.

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