Galemed recalls Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold (REF 1002) due to reports of gas venting below standard pressure. Affected units have specific UDI and lot numbers.
Reports of pressure relief manifold venting gas below the standard pressure.
Galemed is recalling Babi.Plus Bubble PAP Valve devices with a specific pressure relief manifold because they may vent gas below standard pressure. This could cause improper oxygen delivery for patients using the device.
The pressure relief manifold may vent gas at pressures below the intended standard, potentially causing improper oxygen delivery to patients. This could lead to inadequate respiratory support for individuals using the device.
Patients using the Babi.Plus Bubble PAP Valve with the specified model and lot numbers are affected. Those with respiratory conditions requiring precise oxygen delivery are at higher risk.
Check for the UDI number 24710810093559 on the device. Affected units include specific lot numbers: 180718, 181107, 181127, 190220, and reworked products from 190220-190610.
Look for the UDI number 24710810093559 on the device label.
The recall states reports of gas venting below standard pressure, but the device may still be safe for some users. Consult your healthcare provider for specific guidance.
The recall does not specify a remedy, so check with Galemed Corporation for further instructions.
Affected lot numbers include 180718, 181107, 181127, 190220, and reworked products from 190220-190610.
We’ve drafted a message you can send Galemed to request your refund or repair — edit it as you like.
Subject: Recall Z-0021-2020 — Galemed Galemed Hello, I own a Galemed that is covered by recall Z-0021-2020 from Galemed. 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.
