Smiths Medical Recalls Mislabeled Portex-Brand Intubation Connectors

Smiths Medical ASD Inc. (Keene, NH) has announced the recall of one lot of its Portex Low Dead Space Connectors with Sideport. These connectors apparently had been mislabeled as 3.5 mm connectors when they were in fact 3.0 mm parts.

This recall has been given the most serious Class I recall designation because, according to FDA, there is a "reasonable probability that use of these products will cause serious adverse health consequences or death."

The affected products, which are Product Reorder No. 10335-05PS, were distributed in November 2013 and bear the lot number 2553426.

This connector is an intubation accessory used to attach the endotracheal tube to the patient breathing circuit for respiratory support. The sideport on the RSP 15 mm ISO connector allows for the administration of medications and surfactants. Smiths says their low dead space connector is designed with a consistent internal diameter to decrease mechanical dead space and subsequent carbon dioxide rebreathing. The low dead space connectors are available for 2.5, 3.0, and 3.5 mm tube sizes.

On April 10, 2014, Smiths Medical sent an Urgent Medical Device Recall to all affected customers. Smiths advises customers to 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.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Stephen Levy is a contributor to Qmed and MPMN.