Medical Device Regulatory | SCIENCE ARENA
Medical Device Regulatory | SCIENCE ARENA
February 26, 2025 at 02:38 AM
*Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination* *Risk Statement* : Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, contaminated with S. aureus, can result in blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries, caused by nasal irrigation. Resulting secondary infections may occur, such as endocarditis (infection of the heart’s inner lining), bone and joint infections, splenic abscesses or meningitis, and bacterial sinusitis which may lead to eye tissue infections, vision problems, cranial nerve damage, or meningitis. These infections are serious and potentially life-threatening. To date, no adverse events have been reported to Ascent Consumer Products, Inc. related to this recall. SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is used as a nasal wash of the nasal passages to help temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascent-consumer-products-inc-issues-voluntary-nationwide-recall-sinucleanse-soft-tip-squeeze-bottle?utm_medium=email&utm_source=govdelivery

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