FDA-Device2024-01-10Class I
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Busse Hospital Disposables, Inc.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
240
Manufactured in
75 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2024Don't want to check this manually?
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