PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: June 18, 2014 Initiated: April 10, 2014 #Z-1641-2014

Product Description

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.

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.

Details

Recalling Firm
Smiths Medical ASD, Inc.
Units Affected
100 devices
Distribution
US distribution in the state of North Carolina.
Location
Keene, NH

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Smiths Medical ASD, Inc.. Units affected: 100 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2014. Severity: Critical. Recall number: Z-1641-2014.

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