(WHTM) — The U.S. Food & Drug Administration (FDA) has announced the voluntary recall of a sinus nasal wash bottle system following a confirmed test result of microbial contamination.
According to the FDA, Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to a microbial contamination of Staphylococcus aureus (s. aureus).
The FDA says s. aureus contamination can cause various infections for the user which could be serious and potentially life-threatening.
To date, no adverse events have been reported to Ascent Consumer Products, Inc.
The product is mostly used as a nasal wash of the nasal passages to help temporarily relieve symptoms associated with sinusitis, cold, flu, or allergies.
The SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (lot# 024122661A1) was packaged in a carton, containing the squeeze bottle and 30 Saline Packets. The affected lot was distributed nationwide in January through retail and online outlets.
According to the FDA, 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.
Consumers who have the product should discontinue use and immediately return it to the place of purchase or discard it.
If you have any questions, you can contact Ascent Consumer Products Inc. by email at cs@ascentconsumerproducts.com.
If you have any adverse reactions or quality problems with the use of this product, you can report it to the FDA’s MedWatch Adverse Event Reporting program online or by calling 1-800-332-1088.
