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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 Device Recall Low Dead Space Connector with Sideport, 3.5mm see related information
Date Initiated by Firm April 10, 2014
Date Posted June 11, 2014
Recall Status1 Terminated 3 on November 29, 2016
Recall Number Z-1641-2014
Recall Event ID 67991
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 NH 03431-5043
For Additional Information Contact
800-258-5361
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = RESPIRATORY SUPPORT PRODUCTS, INC.
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