Home › Seoil Pacific Corp. › Comfort Cough

Comfort Cough

Seoil Pacific Corp. · Model SICC2001 · UDI-DI 08809517011064

NHJ Prescription

510(k) clearances

189

Adverse events (11 deaths)

Recalls

Facilities

Description

This COMFORT COUGH (SICC2001) is composed of body part, connection tube, and power cable, providing positive pressure gradually and then turning it into negative pressure fast, to make high expiratory pressure to suck up body fluids (secretion in the respiratory tract) just like when people inhale. This product contains a regulator which can control the pressure and the flow so that the user can setup expiratory pressure, suction pressure, and flow. Also, this product contains Bacterial filter to prevent the inflow of body fluids into the body part of the product.

Recalls

Date	Firm	Reason
2026-05-21	Baxter Healthcare Corporation	There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the
2026-05-21	Baxter Healthcare Corporation	There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the
2026-05-21	Baxter Healthcare Corporation	There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the
2026-05-21	Baxter Healthcare Corporation	There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the
2026-02-18	Baxter Healthcare Corporation	Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen l
2024-09-16	Percussionaire Corporation	As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer
2024-05-30	Baxter Healthcare Corporation	Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow
2024-05-30	Baxter Healthcare Corporation	Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow
2022-04-26	Baxter Healthcare Corporation	There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
2022-04-26	Baxter Healthcare Corporation	There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.