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U.S. Department of Health and Human Services

Class 1 Device Recall HUDSON RDI NEONATAL ConchaSmart Breathing Circuit

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  Class 1 Device Recall HUDSON RDI NEONATAL ConchaSmart Breathing Circuit see related information
Date Initiated by Firm May 10, 2019
Create Date July 15, 2019
Recall Status1 Completed
Recall Number Z-1912-2019
Recall Event ID 82994
510(K)Number K173280  
Product Classification Heater, breathing system w/wo controller (not humidifier or nebulizer - Product Code BZE
Product HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
a) REF 870-07KIT
b) REF 870-09KIT

Product Usage:
The proposed Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidified gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotracheal tube with the dual limb configuration.
Code Information Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall		 Teleflex is voluntarily recalling the product referenced above due to reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by email on May 10, 2019. The recall notice requested the returns of the product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For questions contact Customer Service at 1-866-396-2111.
Quantity in Commerce 20 units
Distribution US Nationwide Distribution in the states of AL, TX
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.
510(K) Database 510(K)s with Product Code = BZE and Original Applicant = Teleflex Medical, Inc
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