20 results
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22ms
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Sources: EU EUDAMED, US FDA
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Recall
Terminated
·Life Technologies Corporation·Product code GHQ·February 7, 2018
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JPD·August 18, 2010
Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)
FDA Recall
Terminated
·Datex-Ohmeda·Product code BSF·February 12, 2003
The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.
FDA Recall
Terminated
·Intersurgical Inc·Product code BSF·February 9, 2011
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSF·September 19, 2013
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008
GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code BSF·July 24, 2007
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
FDA Recall
Terminated
·Baro-Therapies, Inc·Product code CBF·August 8, 2014
Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
FDA Recall
Terminated
·GETINGE US SALES LLC·Product code BSF·July 22, 2019
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008
Multi Absorbers, reference number 8003138
FDA Recall
Terminated
·Datex-Ohmeda·Product code BSF·February 12, 2003