Busse Hospital Disposables, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0594-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

Product Classification:

Class I

Date Initiated: November 30, 2023

Date Posted: January 10, 2024

Recall Number: Z-0594-2024

Event ID: 93546

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.

Status: Ongoing

Product Quantity: 240

Code Information:

UDI-DI 00849233011069 Lots 2210087 2210165 2310361

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated