27 results
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84ms
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Sources: EU EUDAMED, US FDA
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code OFP·December 21, 2018
ION
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code EOQ·October 20, 2025
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·March 14, 2014
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
FDA Recall
Terminated
·Intersurgical Inc·Product code OFP·November 11, 2020
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
FDA Recall
Terminated
·Bioseal Corporation·Product code BZA·August 15, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·February 28, 2018
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code BYD·April 29, 2011
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·January 3, 2025
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
FDA Recall
Terminated
·Intersurgical Inc·Product code BSF·February 9, 2011
2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number CDS980652A, Thoracic Anesthesia Pack; 2) Item Number CDS980955, Affinity Shoulder Arthroscopy; 3) Item Number CDS980956, Affinity Total Hip CDS; 4) Item Number CDS980957, Affinity Total Knee CDS; 5) Item Number DYNJAA4758B, Circuit Adult Anesthesia; 6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF; 7) Item Number DYNJAA9796, Anes Circuit 90in EXP Adult-LF; 8) Item Number DYNJAA9847A, Adult Circuit; 9) Item Number DYNJAA9904, Circuit Adult Anesthesia; 10) Item Number DYNJAA9904A, Circuit Adult Anesthesia; 11) Item Number DYNJAA9906, Circuit Adult Anesthesia; 12) Item Number DYNJAA9933, Anesthesia Super Circuit; 13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit; 14) Item Number DYNJAP4726, Pedi Circuit 40in; 15) Item Number DYNJAP4737A, Circuit Pediatric Anesthesia; 16) Item Number DYNJAP4737B, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4737C, Circuit Pediatric Anesthesia; 18) Item Number DYNJAP4744, Pediatric Anesthesia Circuit; 19) Item Number DYNJAP6138, Circuit Pediatric Anesthesia; 20) Item Number DYNJAP7258, Circuit Pediatric Anesthesia; 21) Item Number DYNJAP7259, Peds Anesthesia Circuit; 22) Item Number DYNJAPF6007, Circuit Ped Uni 60in-LF; 23) Item Number DYNJAPF6012, Circuit Pediatric Anesthesia. Medline Industries Inc., Mundelein, IL 60060.
FDA Recall
Terminated
·Medline Industries Inc·Product code BTC·December 7, 2007
Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
FDA Recall
Terminated
·Respironics California Inc·Product code MNS·September 22, 2008
SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.
FDA Recall
Terminated
·Sequal Technologies Inc·Product code CAW·October 1, 2009