Galemed recalls Babi.Plus 12.5 cm H2O Pressure Relief Manifolds with specific UDI and lot numbers due to reports of gas venting below standard pressure. Affected units may pose safety risks.
Reports of pressure relief manifold venting gas below the standard pressure.
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds with certain UDI and lot numbers because they may vent gas below standard pressure. This could lead to safety risks if used improperly.
The pressure relief manifold may vent gas at pressures lower than intended. This could cause the device to malfunction, potentially leading to improper medical treatment or safety issues.
Healthcare professionals using this device for medical purposes are most likely affected. Patients using the device under a doctor's supervision may also be at risk.
Check for the UDI code 04710810093562 on the device. The lot numbers 180718, 181204, 190215, and 190610 are also associated with affected units.
Look for the UDI code 04710810093562 and lot numbers 180718, 181204, 190215, or 190610 on the device.
The recall indicates potential gas venting below standard pressure, so it is not recommended for use until the remedy is applied.
Check the UDI code and lot numbers to see if your device is affected. If it is, contact Galemed for further instructions.
Look for the UDI code 04710810093562 and lot numbers 180718, 181204, 190215, or 190610 on the device.
We’ve drafted a message you can send Galemed to request your refund or repair — edit it as you like.
Subject: Recall Z-0020-2020 — Galemed Galemed Hello, I own a Galemed that is covered by recall Z-0020-2020 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.
