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BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large

Abmrc LLC · Model BK285 · UDI-DI 08500501360129

NHJ Prescription

510(k) clearances

201

Adverse events (11 deaths)

Recalls

Facilities

Description

BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large

Recalls

Date	Firm	Reason
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-18	Percussionaire Corporation	Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2026-08-03	Baxter Healthcare Corporation	Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devi
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

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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.