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.
This recall has been terminated (originally issued June 11, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- April 10, 2014
- Posted
- June 11, 2014
- Terminated
- November 29, 2016
- Recall Number
- Z-1641-2014
- Quantity
- 100 devices
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
Distribution
US distribution in the state of North Carolina.
Lot / Code Info
Lot or Serial No: 2553426
Root Cause
Packaging process control
Action Taken
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.