Z-1912-2019Class I

Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a)...

Name: Z-1912-2019 Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a)...
Creator: Teleflex Medical
Published: 2019-05-10
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-05-10 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 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... on 2019-05-10. FDA classified it as Class I and gives the reason as "Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1912-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-07-15
Terminated: 2024-04-22
Recalling firm: Teleflex Medical
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.
Product code: BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Reason for recall: Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Root cause tag: manufacturing process
FDA root cause: 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 [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.
Quantity in commerce: 20 units
Distribution: US Nationwide Distribution in the states of AL, TX
Product codes and lots: Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1912-2019	Class I	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15

Product code BZE

K173280Class IINeonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. / cleared 2018-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)