Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE Recalled by Busse Hospital Disposables, Inc. Due to Firm is recalling all kits containing recalled lots...

Date: November 30, 2023
Company: Busse Hospital Disposables, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Busse Hospital Disposables, Inc. directly.

Affected Products

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

Quantity: 705

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Busse Hospital Disposables, Inc.

Busse Hospital Disposables, Inc. has 63 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report