Class I Recall of Teleflex NEONATAL ConchaSmart Breathing Circuit

Published: 07/17/2019

Sources:
  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care

Teleflex is recalling the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device. Cracks in the adapter may cause breathing distress because the gas may leak and not reach the patient. Breathing distress from insufficient oxygenation could result in serious adverse health consequences including death.

Teleflex received two complaints about cracks in the adaptor. T

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