FDA MedWatch - Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled

AUDIENCE: Anesthesiology, Risk Manager

ISSUE: FDA notified health professionals of a class 1 recall of this product due to one lot of 3.0mm sized connectors, Lot #2553426, which were mislabeled in packages as 3.5mm. The affected products were distributed in November 2013.

BACKGROUND: The connector is used to attach the endotracheal tube to the patient breathing circuit for respiratory support.

RECOMMENDATION: 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