Recall Z-1641-2014— Smiths Medical ASD, Inc.
Class I · Terminated
Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-04-10, terminated 2016-11-29. It names one FDA 510(k) clearance: K790312. 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.. Reason: One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-04-10
- Terminated
- 2016-11-29
- Firm location
- Keene, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.