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Sources: EU EUDAMED, US FDA
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Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code EZY·October 28, 2024
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
FDA Recall
Terminated
·TELEFLEX-MORRISVILLE·Product code BZD·June 14, 2019
SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.
FDA Recall
Terminated
·Wescor, Inc·Product code HYB·January 6, 2010
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·December 23, 2021
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Recall
Terminated
·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 3, 2024
Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·November 17, 2023
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Recall
Terminated
·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·September 16, 2005
BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code MEG·November 24, 2008
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
FDA Recall
Terminated
·VIASYS Med Systems·Product code CAI·September 10, 2003
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
FDA Recall
Terminated
·VIASYS Med Systems·Product code CAI·September 10, 2003
The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2.6.1 9896 030 19863-SW R 2.6.3
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code LNH·February 5, 2010
HENRY SCHEIN, Amnio Tray, Item No.570-3059,
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HIO·November 2, 2022