Set, Tubing And Support, Ventilator (w Harness)
Anesthesiology · 21 CFR 868.5975
Recent MDR events
1,654 adverse event reports on file
- Breathing Circuit Set, CoaxialJul 30, 2026MalfunctionHamilton Medical Ag3001421318-2026-00461
- Breathing Circuit SetJul 28, 2026MalfunctionHamilton Medical Ag3001421318-2026-00457
- F&P FlexiTrunkJul 28, 2026MalfunctionFisher & Paykel Heathcare Ltd9611451-2026-02315
- Breathing circuit set, coaxialJul 27, 2026MalfunctionHamilton Medical Ag3001421318-2026-00452
- F&P FlexiTrunkJul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02270
- F&P FlexiTrunkJul 27, 2026MalfunctionFisher & Paykel Heathcare Ltd9611451-2026-02301
- F&P FLEXITRUNKJul 8, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02164
- F&P FLEXITRUNKJul 5, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02106
- BREATHING CIRCUIT SETJul 3, 2026MalfunctionHamilton Medical Ag3001421318-2026-00405
- F&P FLEXITRUNKJun 30, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02059
Event type breakdown
Recalls
22 recall events for this product code
- Hamilton Medical AGOpen, ClassifiedJun 30, 2026
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
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 "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Z-2463-2026 · View FDA record ↗ - Percussionaire CorporationOpen, ClassifiedOct 14, 2025
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions
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 high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Z-0031-2026 · View FDA record ↗ - Hamilton Medical AGOpen, ClassifiedJul 30, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
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, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Z-2167-2025 · View FDA record ↗ - Draeger, Inc.Open, ClassifiedApr 3, 2025
Brand Name: ID Circuit
The potential for cracks forming in the breathing circuit hose.
Z-1494-2025 · View FDA record ↗ - Percussionaire CorporationOpen, ClassifiedSep 27, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Z-3207-2024 · View FDA record ↗ - Percussionaire CorporationOpen, ClassifiedSep 27, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
Z-3208-2024 · View FDA record ↗ - Mallinckrodt Manufacturing LLCOpen, ClassifiedSep 9, 2023
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Z-2450-2023 · View FDA record ↗ - Draeger Medical, Inc.TerminatedMay 17, 2023
ID Circuit Basic (P) 180, MP01340
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1446-2023 · View FDA record ↗ - Draeger Medical, Inc.TerminatedMay 17, 2023
VentStar Coax (P) 150, MP00379
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1451-2023 · View FDA record ↗ - Draeger Medical, Inc.TerminatedMay 17, 2023
Ventstar Coax, MP03373
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Z-1454-2023 · View FDA record ↗
Registered firms
154 firms currently registered for this product code
C2c Development, Llc
Melbourne, FL, US
Guangzhou Schauenburg-truplast Hose Technology Ltd.
Guangzhou Guangdong, CN
Zhejiang Guanghua Medical Hose Technology Co., Ltd.
Jiaxing City Zhejiang, CN
Vadi Medical Technology Co., Ltd.
Taoyuan City, TW
Hangzhou Shanyou Medical Equipment Co.,ltd
Hangzhou Zhejiang, CN
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Dima Italia Srl
Bologna, IT
Bomimed Inc.
WINNIPEG, Manitoba, CA
Maquet Critical Care Ab
SOLNA Stockholm, SE
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Guang Dong Eda Technology Co., Ltd.
Dongguan City Guangdong, CN
Headstar Medical Products Co., Ltd
NEW TAIPEI CITY, TW
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Instrumentation Industries, Incorporated
BETHEL PARK, PA, US
Vbm Medizintechnik Gmbh
SULZ AM NECKAR Baden-Wurttemberg, DE
Resmed Corp
San Diego, CA, US
Bmc Medical Co., Ltd.
Fengtai District Beijing, CN
Evereast Medical Products Group Co., Ltd
Changyuan City Henan, CN
Create Biotech Co., Ltd.
Taoyuan City, TW
Bmc(dongguan) Medical Co., Ltd.
Dongguan Guangdong, CN
Pepper Medical, Inc.
West Chester, PA, US
Int'air Medical
MONTAGNAT Ain, FR
Exceleron Medical, Llc
Saint Paul, MN, US
Ningbo Shengyurui Medical Appliance Co.
Ningbo Zhejiang, CN
510(k) clearances
88 clearances for this product code
- Unicor, Inc.Sep 19, 1995
K953784 · UNICOR, INC. CORRUGATED TUBING
- Unicor, Inc.Sep 18, 1995
K953785 · UNICOR, INC. VENTILATOR HOSES
- Prima, Inc.May 22, 1995
K952010 · PRIMA VENTILATOR HOSES
- Prima, Inc.May 22, 1995
K952022 · PRIMA VOLUMN VENTILATORSS
- Prima, Inc.May 22, 1995
K952012 · PRIMA CUSTOM ANESTESIA CIRCUIT
- Prima, Inc.May 22, 1995
K952011 · PRIMA BREATHING BAGS
- Hamilton Medical, Inc.Mar 23, 1995
K945740 · INFANT FLOW SYSTEM
- Prima, Inc.Dec 2, 1994
K944531 · PRIMA, INC. CORRUGATED TUBING