Agency classClass IOur severity:Severe FDA (Devices)·Z-0020-2020·Announced 2020-01-01

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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Reports of pressure relief manifold venting gas below the standard pressure."

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
Category: Medical Device — Pressure Relief Manifold
Hazard: pressure-defect
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

Distributed in 2 states:

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 →

Same manufacturer · Galemed Corporation

See all →

Critical
Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
FDA (Devices) · 2020-01-01
Severe
Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect
FDA (Devices) · 2020-01-01

Same hazard · pressure defect