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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Galemed Corporation: Reports of pressure relief manifold venting gas below the standard pressure.

Agency Publication Date: December 20, 2019
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Affected Products

Product: Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)

Lot Numbers:
180718
Product: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)

Lot Numbers:
180718
Product: Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

UDI: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327

Lot Numbers:
180806

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83318
Status: Resolved
Manufacturer: Galemed Corporation
Manufactured In: Taiwan
Units Affected: 3 products (2880; 12000; 14964)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.