Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Galemed Corporation is recalling the Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port (REF 2691). The recall is due to reports that the pressure relief manifold may vent gas below the standard pressure. The affected product is prescription-only and is identified by UDI 04710810100802.
The recall involves 14,964 units. The affected lots are 180806, 180910, 181029, 181105, 181204, 190225, and 190327. These units were distributed in the United States to distributors in the states of North Carolina and Nevada.
Healthcare providers and patients should stop using the affected devices and contact Galemed Corporation for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
- Manufacturer
- Galemed Corporation
- Hazard
- Affected units
- 14,964
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 (7)
- UDI: 04710810100802 Lot: 180806
- 180910
- 181029
- 181105
- 181204
- 190225
- 190327
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
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- SevereGalemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
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