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HUDSON RCI

TELEFLEX INCORPORATED · Model IPN045186 · UDI-DI 04026704597970

BZO Prescription

510(k) clearances

1,654

Adverse events (22 deaths)

Recalls

150

Facilities

Description

Neonatal Universal Ventilator Circuit Single Heated Limb (21 V) with 18" Remote Temperature Port

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.