Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff - Class 1 Recall
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2015 Category: Medical Equipment Source Type: alerts
Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless - Class 1 Recall
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P, (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless - Class 1 Recall
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P, (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2015 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff - Class 1 Recall
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2015 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Flowi Anesthesia System - Class 1 Recall
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2015 Category: Medical Equipment Source Type: alerts
Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Puritan Bennett 980 Ventilator System - Class 2 Recall
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal t...
Source: Medical Device Recalls - February 6, 2015 Category: Medical Equipment Source Type: alerts
Natus Medical Incorporated - Natus neoBLUE 2 Phototherapy system - Class 2 Recall
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2014 Category: Medical Equipment Source Type: alerts
INO Therapeutics (dba Ikaria) - INOmax DSIR - Class 2 Recall
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Respironics California Inc - Esprit V1000 Ventilator - Class 2 Recall
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2014 Category: Medical Equipment Source Type: alerts
Nellcor Puritan Bennett Inc. (dba Covidien LP) - Class 1 Recall
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 29, 2014 Category: Medical Equipment Source Type: alerts
Respironics California Inc - Esprit V1000 Ventilator, V200 Ventilator - Class 1 Recall
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2014 Category: Medical Equipment Source Type: alerts
Genesis BPS, LLC. - Class 2 Recall
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2014 Category: Medical Equipment Source Type: alerts
Genesis BPS, LLC. - Class 2 Recall
Pedi-Pak Pedi-Syringe Filter 35 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2014 Category: Medical Equipment Source Type: alerts
Genesis BPS, LLC. - Class 2 Recall
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2014 Category: Medical Equipment Source Type: alerts
Spacelabs Healthcare Inc - ARIATELE TELEMETRY TRANSMITTER, Model 96281 - Class 2 Recall
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2014 Category: Medical Equipment Source Type: alerts
