Medical Device Recall: Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Busse Hospital Disposables, Inc. · November 30, 2023
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
536
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0593-2024
Status: ongoing
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