Teleflex Neonatal Breathing Circuit Recall Due to Cracked Adaptors

Plain-English summary

Teleflex Medical is recalling 20 units of the HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column. The affected products are identified by reference numbers 870-07KIT and 870-09KIT, with specific lot numbers 74L1802045 and 74L1802044. These devices are intended to deliver humidified breathing gases to infant and neonate patients.

The recall was initiated due to reported complaints of cracks being observed on the swivel wye adaptors of the breathing circuits. These defects were noted prior to the use of the devices. The agency has classified this as a Class I recall.

The products were distributed nationwide in the United States, specifically in the states of Alabama and Texas. Consumers and healthcare facilities should stop using the affected units and contact Teleflex Medical for instructions on return or replacement.

The recalled product

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 a

Manufacturer

Teleflex Medical

Category

Medical Device — Respiratory

Hazard

• structural-defect

Affected units

20

Distribution

Related recalls