Philips Respironics, Inc. - Trilogy EVO - Class 1 Recall
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2020 Category: Medical Devices Source Type: alerts
Philips Respironics, Inc. - Trilogy EVO - Class 1 Recall
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 16, 2020 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - DP30 Digital Ultrasonic Diagnostic Imaging System - Class 2 Recall
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, muscular-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vascular and urology exams. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Centurion Dressing Change Kits - Class 2 Recall
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING CHANGE KIT DYNDC1870A SMALL DRESSING KIT DYNDC1945B PORT ACCESS KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1996B CENTRAL LINE DRESSING CHANGE DYNDC2004A IVAD KIT DYNDC20...
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - CenturionSurgical Tray - Class 2 Recall
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT P...
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Centurion Dressing Change Tray - Class 2 Recall
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850 PORT DRESSING CHANGE TRAY DT11300 DIALYSIS ON/OFF KIT DT11610 DRESSING CHANGE TRAY DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG DT12220 CVC DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12485 PEDI CENT ...
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Arrow International Inc - Class 2 Recall
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Carestation 620/650/650c A2 - Class 1 Recall
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Carestation 620/650/650c A1 - Class 1 Recall
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTIS Pheno - Class 2 Recall
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2020 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - Halyard Closed Suction System for Neonates/Pediatrics (5 Fr) - Class 2 Recall
Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code 109838302. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 9, 2020 Category: Medical Devices Source Type: alerts
Stryker GmbH - Class 2 Recall
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2020 Category: Medical Devices Source Type: alerts
Medical Action Industries, Inc. 306 - Kit, surgical instrument, disposable - Class 2 Recall
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change Kit, REF 74636C Central Line Dressing Kit, VCU, REF 57647B Central Line Removal Kit, REF 78631B Chest Tube Cleaning Kit, REF 73000 CVC Dressing Change Kit, REF 80643D Dressing Change Kit, REF 71538 ED Suture Set, REF 59299C Laceration Kit, REF 59806B Laceration Tray, REF 56957 Laceration Tray, REF 57888B Lace...
Source: Medical Device Recalls - January 7, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CIC Pro Clinical Information Center Central Station - Class 2 Recall
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - CARESCAPE Central Station - Class 2 Recall
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2019 Category: Medical Devices Source Type: alerts
