Ventec recalls pediatric oxygen breathing packages with spiral wrap that may detach during use, risking leaks or occlusions that could cause serious injury or death, especially for ventilator-dependent patients.
The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.
Ventec is recalling pediatric oxygen breathing packages that may detach during use, potentially causing leaks or blockages in the breathing circuit. This poses a serious risk of injury or death, particularly for patients who rely on ventilators.
The spiral wrap can detach due to a manufacturing defect, which may compromise the breathing circuit's structure. This can lead to leaks or blockages that could cause serious injury or death during ventilation.
Patients using this breathing package for ventilator support are most at risk. Ventilator-dependent individuals are especially vulnerable to serious injury or death if the spiral wrap detaches.
Check for the package with part number PRT-01013-000 and pouch part number PRT-00802-001. This product was sold with the VOCSN Unified Respiratory System for ventilator support.
Immediately stop using the recalled breathing package as it may detach and cause serious injury or death.
The spiral wrap may detach during ventilation due to a manufacturing issue, which can compromise the breathing circuit and cause serious injury or death.
Ventilator-dependent patients are at the highest risk of serious injury or death if the spiral wrap detaches.
Look for the package with part number PRT-01013-000 and pouch part number PRT-00802-001, sold with the VOCSN Unified Respiratory System.
We’ve drafted a message you can send Ventec to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2024 — Ventec Ventec Hello, I own a Ventec that is covered by recall Z-1070-2024 from Ventec. 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.