Teleflex Neonatal Breathing Circuit Recall Due to Cracked Adaptors
Teleflex is recalling 20 units of Neonatal ConchaSmart Breathing Circuits due to reported cracks on swivel wye adaptors observed prior to use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 (Critical) according to the rubric.
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…
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 20
Distribution
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