Date Initiated by Firm | May 10, 2019 |
Date Posted | July 15, 2019 |
Recall Status1 |
Terminated 3 on April 22, 2024 |
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
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Product | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
a) REF 870-07KIT
b) REF 870-09KIT
Product Usage:
The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. 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
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For Additional Information Contact | Customer Service 866-396-2111 |
Manufacturer Reason for Recall | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
FDA Determined Cause 2 | Process control |
Action | The firm initiated the recall by email on May 10, 2019. The recall notice requested the return 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 |
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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.
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510(K) Database | 510(K)s with Product Code = BZE
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