Medical Devices

Smiths Medical - Portex Low Dead Space Connector with Sideport, 3.5mm

Recall Class: Class I

Date Recall Initiated: April 10, 2014

Product: Low Dead Space Connectors with Sideport, Product Reorder No. 10335-05PS

The affected products were distributed in November 2013.

Lot Number: 2553426

Use: The connector is used to attach the endotracheal tube to the patient breathing circuit for respiratory support. The low dead space connector is designed to decrease mechanical dead space and subsequent carbon dioxide rebreathing.

Recalling Firm:
Smiths Medical ASD, Inc.
10 Bowman Dr.
Keene, NH 03431

Reason for Recall:  One lot of 3.0mm sized connectors, Product Reorder No. 10035-05PS, Lot 2553426 were placed in packages labeled as 3.5mm.

Public Contact: For questions about this recall, customers may contact Smiths Medical’s Customer Service Department at 1-800-258-5361.

FDA District: New England District Office

More Information about this Recall: 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.

About Class I Recalls: Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

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.

Page Last Updated: 06/12/2014
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