Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a performance defect (venting below standard pressure) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Galemed Corporation is recalling the Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030. The recall involves 2,880 units distributed in the United States to distributors in North Carolina and Nevada. The affected lots are 180718, 181204, 190215, and 190610 (Reworked Product), identified by UDI 04710810093562.
The recall was initiated due to reports that the pressure relief manifold vents gas below the standard pressure. This deviation from the specified pressure standard may affect the performance of the medical device.
Healthcare providers and distributors should stop using the affected devices and contact Galemed Corporation for instructions on return or replacement. Patients using these devices should consult their healthcare provider regarding the recall and potential alternatives.
The recalled product
- Product
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
- Manufacturer
- Galemed Corporation
- Hazard
- Affected units
- 2,880
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 04710810093562 Lot: 180718
- 181204
- 190215
- and 190610 (Reworked Product)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Galemed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Galemed Corporation
See all →- CriticalGalemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
FDA (Devices) · 2020-01-01
- SevereGalemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect
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