Smiths Medical has issued an urgent medical device correction for certain sizes of its Portex intubation oral/nasal endotracheal tubes due to a manufacturer defect that results in a smaller-than-expected diameter.
The affected tube sizes including 2.0, 2.5, 3.0 and 3.5 mm, pose a serious risk of inadequate ventilation, which could lead to hypoxia, overdose, cardiopulmonary collapse or death, according to a March 10 news release from the FDA.
Affected customers and distributors have been notified and provided instructions for identifying the affected products. The company has received eight reports of serious injuries linked to this issue.
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