Busse Hospital Disposables, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0592-2024)
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. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Product Classification:
Class I
Date Initiated: November 30, 2023
Date Posted: January 10, 2024
Recall Number: Z-0592-2024
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: 705
Code Information:
UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Distribution Pattern:
US Nationwide distribution.
Voluntary or Mandated:
Voluntary: Firm initiated