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Sources: EU EUDAMED, US FDA
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Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·April 7, 2025
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·April 7, 2025
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·May 29, 2024
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
FDA Recall
Terminated
·Cardiac Science Corporation N7·Product code MKJ·January 14, 2016
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
FDA Recall
Terminated
·Cenorin, LLC·Product code LDS·April 9, 2018
Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·June 29, 2011
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. The product is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***[email protected]***'. The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
FDA Recall
Terminated
·O'Ryan Industries Inc·Product code EBZ·April 23, 2012
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code BZO·June 1, 2015
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code BZO·June 1, 2015
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Recall
Open, Classified
·Hamilton Medical AG via Crusch 8 Bonaduz Switzerland·Product code CBK·March 12, 2018
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code BZO·June 1, 2015
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Recall
Open, Classified
·Hamilton Medical AG via Crusch 8 Bonaduz Switzerland·Product code CBK·March 12, 2018
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.
FDA Recall
Terminated
·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·March 9, 2018
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code CBK·April 22, 2014
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.
FDA Recall
Open, Classified
·Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland·Product code BZO·June 26, 2025
HAMILTON-C6, REF: 160021
FDA Recall
Open, Classified
·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·March 14, 2023
HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Recall
Completed
·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code BTT·January 5, 2021