medical Class I Updated 2024-01-10

Busse Hospital Disposables, Inc. recalls Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET /

Recalled Product

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / 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 00849233011069 Lots 2210087 2210165 2310361
View official government recall

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