One lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System is under recall after a ‘confirmed test result of microbial contamination of the product with Staphylococcus aureus (S. aureus)’, according to a US Food and Drug Administration (FDA) notice.
The bacteria can cause blood infections in users with inflammation or injuries in their nasal mucosa.
Secondary adverse effects can include infections of the heart’s lining, bones and joints; splenic abscesses or meningitis; and bacterial sinusitis which can develop into cranial nerve damage, eye tissue infections and other vision issues.
‘These infections are serious and potentially life-threatening,’ stated the FDA notice.
SinuCleanse is a nasal wash that temporarily helps relieve sinusitis, flu, cold and allergies.
Ascent Consumer Products Inc, which is based in Melville, New York, announced the voluntary recall on Tuesday for the product with the lot number 024122661A1 and expiration date of December 31, 2027.
The affected product was distributed in January at retail locations and online around the US.
Customers with the product are advised to return it for replacement or throw it away.
No health issues have yet been reported linked to the item.
Customers with concerns should contact Ascent Consumer Products Inc.
It comes just over a week after ICU Medical voluntarily recalled its IV bags of potassium chloride due to a labeling problem that could cause a healthcare provider to administer a patient the wrong amount.
Overdoses of the drug commonly used in hospitals could lead to neuromuscular disfunction including weakness, paralysis, confusion and cardiac arrest resulting in death.
No illnesses were reported from the IV bags. But an FDA advisory warned that premature infants, patients with cardiac arrythmias or on chronic parenteral nutrition, patients with chronic renal insufficiency or acute renal failure and patients on potassium-sparing diuretics ‘all are at risk for adverse and potentially fatal outcomes’.
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