medical Class I Updated 2024-01-10

Busse Hospital Disposables, Inc. recalls Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
View official government recall

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