HUDSON RCI recallZ-1912-2019 · Teleflex Medical · initiated May 10, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
FDA root cause category: Process control
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-1912-2019
- Status
- Terminated
- Initiated by the company
- May 10, 2019
- Posted by the FDA
- Jul 15, 2019
- Recalling firm
- Teleflex Medical
- Quantity
- 20 units
- Product code
- BZE
- FDA submissions
- K173280
- Distribution
- US Nationwide Distribution in the states of AL, TX
Product description
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 (models, lots, serial numbers)
Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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