Reference: 2404-0136
Product: N/A
Hazard: The product has been identified as presenting a microbiological risk as testing found the product to contain microbial contamination identified as Microbacterium sp, Fictibacillus sp, Bacillus sp, (primarily B. malikii), and Paenibacillus sp. In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection. The product does not meet the requirements of the General Product Safety Regulations 2005.
Corrective Action: The product has been recalled from end users.
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