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U.S. Department of Health and Human Services

Class 1 Device Recall Low Dead Space Connector with Sideport, 3.5mm

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 Class 1 Recall
Low Dead Space Connector with Sideport, 3.5mm
see related information
Date Posted June 11, 2014
Recall Status1 Open
Recall Number Z-1641-2014
Recall Event ID 67991
Premarket Notification
510(K) Number
K790312 
Product Classification Tube, Tracheal (W/Wo Connector) - Product Code BTR
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.
Code Information Lot or Serial No: 2553426
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene, New Hampshire 03431-5043
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action 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.
Quantity in Commerce 100 devices
Distribution US distribution in the state of North Carolina.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = RESPIRATORY SUPPORT PRODUCTS, INC.
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