—#173297

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.

FDA product code: BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K173280
Affected lot / code info: Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161

Why it was recalled

Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US Nationwide Distribution in the states of AL, TX

Timeline

Recall initiated: 2019-05-10
Posted by FDA: 2019-07-15
Terminated: 2024-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.