Teleflex-Morrisville recalls Babi.Plus 12.5 cm H2O Pressure Relief Manifold (Catalog # 2691) due to potential venting of gas below stated pressure levels when used with ventilators.
Device vented gas below the stated pressure.
Teleflex-Morrisville is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds (Catalog # 2691) because they may vent gas below the stated pressure when used with ventilators. This could lead to inadequate ventilation support for patients.
The device may vent gas below the stated pressure when used with ventilators. This could result in insufficient ventilation support for patients, potentially affecting their breathing safety.
Patients using ventilators with this specific manifold may be at risk if the device vents gas below the stated pressure. Healthcare facilities and ventilator users should check if they have the recalled model.
Check for Catalog # 2691 with SKU XTF0046. Lot numbers include 180806, 180910, 181029, 181105, 181204, 190225, and 190327. The product is sold with ventilators.
Identify the catalog number (2691) and SKU (XTF0046) to confirm if your manifold is recalled.
The recall indicates a potential risk of venting gas below stated pressure levels, which could affect ventilation support. However, the hazard is not described as causing serious injury in normal use.
Look for Catalog # 2691 with SKU XTF0046 and lot numbers 180806, 180910, 181029, 181105, 181204, 190225, or 190327.
The recall does not specify a remedy, so you should contact Teleflex-Morrisville directly for guidance.
We’ve drafted a message you can send Teleflex-Morrisville to request your refund or repair — edit it as you like.
Subject: Recall Z-0009-2020 — Teleflex-Morrisville Teleflex-Morrisville Hello, I own a Teleflex-Morrisville that is covered by recall Z-0009-2020 from Teleflex-Morrisville. 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.
