67 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Recall
Terminated
·BEST THERATRONICS LTD.·Product code MOT·May 6, 2016
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code ITX·August 24, 2021
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code GYB·August 24, 2021
Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
FDA Recall
Terminated
·Preservation Solutions Inc·Product code KDN·September 24, 2010
Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.
FDA Recall
Terminated
·Sigma-Aldrich Mfg LLC·Product code JCF·December 8, 2009
HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. The firm name on the label is HACH Company, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
FDA Recall
Terminated
·Hach Co·Product code FKP·May 23, 2008
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·June 26, 2012
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
FDA Recall
Terminated
·Thornhill Research Inc·Product code BTL·November 19, 2015
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Recall
Terminated
·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Recall
Terminated
·O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario·Product code BTL·February 12, 2019
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare·Product code BTL·December 12, 2013
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
FDA Recall
Open, Classified
·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·August 30, 2024
Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code BTL·May 16, 2007
Model 73X Uni-Vent Product Usage: Intended for use at mass casualty incidents.
FDA Recall
Terminated
·Impact Instrumentation, Inc.·Product code BTL·November 4, 2011
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·October 15, 2012
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Recall
Terminated
·O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario·Product code BTL·February 12, 2019
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code BTL·February 7, 2024
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
FDA Recall
Open, Classified
·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·December 10, 2024
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
FDA Recall
Terminated
·Thornhill Research Inc·Product code BTL·November 19, 2015
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTL·September 7, 2012