Busse Hospital Disposables, Inc. recalls Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Recall date

November 30, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0593-2024

FDA classification

Class I

Brand / firm

Busse Hospital Disposables, Inc.

Sold / distributed

US Nationwide distribution.

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE