Teleflex Medical recalls Neonatal ConchaSmart Breathing Circuits with dual heated limbs due to reported cracks in swivel wye adaptors before use. This could lead to breathing gas delivery issues for infants.
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Teleflex Medical is recalling neonatal breathing circuits that have reported cracks in swivel adaptors before use. These cracks could cause breathing gas delivery problems for infants if the circuit is used.
Cracks in the swivel wye adaptors could allow air leaks or improper gas delivery to infants. This might lead to breathing difficulties if the circuit is used before the cracks are fixed.
Infants using neonatal breathing circuits with Teleflex ConchaSmart Dual Heated Limb models. Healthcare providers who use these circuits for neonatal care are most at risk.
Check for the model numbers REF 870-07KIT or REF 87: 870-09KIT. These circuits were sold with lot numbers GTIN 14026704611154 or 14026704611161.
Inspect the swivel wye adaptors for cracks before use. If cracks are found, stop using the circuit immediately.
Reported complaints of cracks in swivel wye adaptors before use, which could lead to breathing gas delivery issues for infants.
The affected models are REF 870-07KIT and REF 870-09KIT with lot numbers GTIN 14026704611154 or 14026704611161.
Check for the model numbers REF 870-07KIT or REF 870-09KIT and lot numbers GTIN 14026704611154 or 14026704611161.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2019 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1912-2019 from Teleflex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
