Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect
Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Galemed Corporation is recalling 12,000 units of the Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002. The recall involves specific lots: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product). The product is identified by UDI 24710810093559.
The recall was initiated due to reports that the pressure relief manifold vents gas below the standard pressure. This defect could potentially affect the performance of the medical device.
The affected units were distributed in the United States to distributors in North Carolina and Nevada. Healthcare providers and patients should check their inventory and discontinue use of the affected lots. Galemed Corporation is the recalling firm.
The recalled product
- Product
- Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
- Manufacturer
- Galemed Corporation
- Hazard
- Affected units
- 12,000
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 (5)
- UDI: 24710810093559 Lot: 180718
- 181107
- 181127
- 190220
- and 190220-190610 (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 Pressure Relief Manifold Recalled for Low Venting Pressure
FDA (Devices) · 2020-01-01
Same hazard · pressure defect
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