# FDA recall Z-0592-2024

> **Busse Hospital Disposables, Inc.** · Class I · device recall initiated 2023-11-30.

## Product

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

## Reason for recall

Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0592-2024
- **Recalling firm:** Busse Hospital Disposables, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-30
- **Report date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2024

## Citation

> AI Analytics. FDA recall Z-0592-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0592-2024. Source: US FDA. Licensed CC0.

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