Galemed recalls Babi.Plus 12.5 cm H2O Pressure Relief Manifolds with gas supply tube and oxygen sensor port (REF 2691) due to reports of gas venting below standard pressure. Affected units include specific lot numbers from 2018-2019.
Reports of pressure relief manifold venting gas below the standard pressure.
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds with gas supply tube and oxygen sensor port (REF 2691) because they may vent gas below standard pressure. This could lead to unsafe gas levels in medical devices, potentially causing injury if used improperly.
The pressure relief manifold may vent gas below standard pressure levels, which could lead to unsafe gas concentrations in the device. This might cause improper oxygen delivery or unintended gas release during use, potentially causing injury if the device is not properly monitored.
Medical device users who own the Babi.Plus 12.5 cm H2O Pressure Relief Manifold with gas supply tube and oxygen sensor port (REF 2: 2691) are affected. Patients using this device for medical oxygen therapy are most at risk.
Check for the model number REF 2691 on the device. Affected units include specific lot numbers from 2018-2019: 180806, 180910, 181029, 181105, 181204, 190225, 190327.
Look for the model number REF 2691 and the specific lot numbers listed in the recall notice.
The recall states reports of gas venting below standard pressure, but no specific remedy is provided. The device may not be safe if it vents gas below standard pressure levels.
Check for the model number REF 2691 and lot numbers 180806, 180910, 181029, 181105, 181204, 190225, or 190327.
The recall does not specify a remedy, so no action is required based on the official notice. However, the device may be unsafe if it vents gas below standard pressure.
We’ve drafted a message you can send Galemed to request your refund or repair — edit it as you like.
Subject: Recall Z-0022-2020 — Galemed Galemed Hello, I own a Galemed that is covered by recall Z-0022-2020 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.
