Teleflex Medical: Medical Device Recall in 2019 - (Recall #: Z-1912-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: May 10, 2019

Date Posted: July 24, 2019

Recall Number: Z-1912-2019

Event ID: 82994

Reason for Recall:

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

Status: Terminated

Product Quantity: 20 units

Code Information:

Lot/ Batch Number GTIN a) 74L1802045 14026704611154 b) 74L1802044 14026704611161

Distribution Pattern:

US Nationwide Distribution in the states of AL, TX

Voluntary or Mandated:

Voluntary: Firm initiated