TOPIC: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System by Ascent Consumer Products: Recall - Due to Microbial Contamination
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Otolaryngology
ISSUE: Ascent Consumer Products Inc. is recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus).
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 related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: 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.
RECOMMENDATIONS:
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Consumers should contact their physician or health care provider if they experience any problems related to the use of this product.
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Consumers who have this product should discontinue use immediately and return it to the place of purchase or discard it.
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Consumers with questions regarding this recall can contact Ascent Consumer Products by email at cs@ascentconsumerproducts.com.
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Distributors and retailers in possession of the affected lot should immediately cease distribution and remove the recalled SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System lot from inventory.
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