Smiths Medical ASD Inc. - Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube - Class 2 Recall
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 29, 2020 Category: Medical Devices Source Type: alerts
Avanos Medical, Inc. - CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ AntiIV Connector - Class 2 Recall
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 8, 2020 Category: Medical Devices Source Type: alerts
Covidien Llc - Puritan Bennett 980 (PB980) Ventilator - Class 2 Recall
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ 980X3SVAIQC 980U3ENASAA 980U1ENDICU 980U1FRDICU 980X3ENDRAC 980X1FRDISS 980A3ENNISB 980X1PLDIPC 980X3SKNISC 980U3ESDIUU 980X1DEDISS 980X3DEDISS 980X3HUNISC 980X3ENDIPP 980X1BGDRAC 980X1ENDRAC 980X1NLDRAC 980A1ENNISB 980X3TRDRAC 980X3CSNISC 980U3ESDIUC 980U1ENASAA 980X1JADIJJ 980X1FRAIQC 980X1ENDIPC 980X1ENNISB 9...
Source: Medical Device Recalls - November 7, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Aisys CS2 - Class 2 Recall
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 31, 2020 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Avance CS2 - Class 2 Recall
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 31, 2020 Category: Medical Devices Source Type: alerts
Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts
Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts
CareFusion 303, Inc. - BD Alaris System - Class 2 Recall
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2020 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Holder HKHZ 19 for use with Quadroxi and QuadroxiD Neonatal / Pediatric Oxygenators - Class 2 Recall
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2020 Category: Medical Devices Source Type: alerts
Westmed, Inc. - NeoVent Infant TPiece Resuscitation Circuit - Class 2 Recall
Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Mediana Co., Ltd. - DIRECT SUPPLY Attendant VITAL SIGNS MONITOR - Class 2 Recall
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare, Inc. - Spacelabs Healthcare Xhibit Central Station (96102) - Class 2 Recall
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 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 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
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
