Smiths Medical Portex Low Dead Space Connector with Sideport 3.5mm Recalled (Class I) Because One Lot Was Mislabeled
The US FDA informs Anesthesiologists and Risk Managers that one lot of Portex Low Dead Space Connector with Sideport 3.5mm, by Smiths Medical, is recalled because it was mislabeled.
Background of Portex Low Dead Space Connector
Portex Low Dead Space Connector is used to attach the endotracheal tube to the patient breathing circuit for respiratory support.
FDA Alert on Portex Low Dead Space Connector
FDA’s reason for the recall is that one lot of 3.0mm sized connectors, Lot #2553426, which were mislabeled in packages as 3.5mm.
The affected lot number is Lot #2553426 and was distributed in November 2013.
The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
FDA Recommendation on Portex Low Dead Space Connector
“On April 10, 2014, Smiths Medical sent an Urgent Medical Device Recall to all affected customers. Customers should examine their inventory, remove all affected products and returned the completed Response Form and affected products to Smith Medical. Customers with questions were instructed to contact Smiths Medical’s Customer Service Department at 1-800-258-5361.”
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