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U.S. Department of Health and Human Services

Class 2 Device Recall HUDSON RCI, Humidifier Adaptor

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  Class 2 Device Recall HUDSON RCI, Humidifier Adaptor see related information
Date Initiated by Firm June 06, 2011
Date Posted July 12, 2011
Recall Status1 Terminated 3 on May 01, 2014
Recall Number Z-2790-2011
Recall Event ID 59035
510(K)Number k993355  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709.

Use to add water vapor to a dry medical gas for administration to a patient.
Code Information Catalog Number: 003-40, Lot numbers: 738107, 741107, 762107, 764107 and 766107; Catalog number: 003-40F, Lot number: 733107; Catalog number: 003-40J, Lot number: 740107; Catalog number: 000-40, Lot numbers: YK24 and YL11; Catalog number: 006-40, Lot number: 137106; Catalog number: 006-40F, Lot numbers: 122106 and 123106; Catalog number: 006-40J, Lot numbers: 135106 and 136106; Catalog number: 400340, Lot numbers: 730107, 731107, 732107, 734107 and 735107.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Robert Phillips
610-378-0131
Manufacturer Reason
for Recall		 The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.
FDA Determined
Cause 2		 Packaging
Action Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 6, 2011 to all affected customers. The letter described the product, problem, and the action to be taken. The letter instructs customers to discontinue use and quarantine the affected product. Customers must complete and return a Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service. A representative will contact customers with instructions on how to return the affected product. Customers with no affected product are also instructed to complete and return the form to verify receipt of the notification. Contact Customer Service at 1-866-246-6990 if you have questions regarding this recall. and a record of returns. A third letter was addressed to the Risk Manager with the above instructions.
Quantity in Commerce 228, 960 eaches
Distribution Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MI, MN, MO, MS, NM, NE, NY, OH, OK, PA, TX, VA, WI and WM and the countries of Japan, Philippines, and Thailand.
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 = BTT and Original Applicant = HUDSON RESPIRATORY CARE, INC.
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