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U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 3

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  Class 2 Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 3 see related information
Date Initiated by Firm March 23, 2007
Date Posted June 07, 2007
Recall Status1 Terminated 3 on November 16, 2009
Recall Number Z-0860-2007
Recall Event ID 37665
510(K)Number K871157  
Product Classification CPAP - Product Code BZD
Product Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1693: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;
Code Information Catalog no. 1693, lot numbers 32069/21406, 32069/21506
Recalling Firm/
Manufacturer		 Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall		 The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Quantity in Commerce 13,530 for all products
Distribution Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela
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 = BZD and Original Applicant = HUDSON OXYGEN THERAPY SALES CO.
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