—#126747

Product

Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K790312
Affected lot / code info: Lot or Serial No: 2553426

Why it was recalled

One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

Root cause (FDA determination)

Packaging process control

Action the firm took

Smiths Medical sent an Urgent Medical Device Recall Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine all affected products and to complete the attached Response Form and return it to Smith Medical within 7 days of receipt of the notice. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at +1-800-258-5361.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: US distribution in the state of North Carolina.

Timeline

Recall initiated: 2014-04-10
Posted by FDA: 2014-06-11
Terminated: 2016-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.