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Classic RT

Plastiflex Group NV · Model Classic RT19 x 300 Blue · UDI-DI 05404013002016

BZO

510(k) clearances

1,654

Adverse events (22 deaths)

Recalls

150

Facilities

Recalls

Date	Firm	Reason
2026-07-13	Medline Industries, LP	Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,
2026-05-29	Hamilton Medical AG	Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalati
2025-09-17	Percussionaire Corporation	IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at
2025-06-26	Hamilton Medical AG	Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows,
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2024-08-21	Percussionaire Corporation	Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
2024-08-21	Percussionaire Corporation	Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
2023-08-08	Mallinckrodt Manufacturing LLC	The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
2023-04-17	Draeger Medical, Inc.	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
2023-04-17	Draeger Medical, Inc.	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

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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.