205 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
FDA Recall
Terminated
·Arrow International Inc·Product code LJS·April 11, 2018
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 2, 2016
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·January 14, 2016
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 2, 2016
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·January 14, 2016
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 10, 2015
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Enforcement
Class II
·Terminated·Smith & Nephew Inc·May 25, 2022
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 28, 2021
Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code GJT·May 11, 2015
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 26, 2019
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Recall
Terminated
·Arrow International Inc·Product code PND·April 23, 2019
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject 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.
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
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
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject 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
FDA Recall
Terminated
·Genesis BPS, LLC.·Product code BRZ·July 17, 2014
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·December 1, 2010
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JPA·March 2, 2021
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JWH·April 19, 2022
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
FDA Recall
Terminated
·Bard Access Systems·Product code LJT·March 18, 2010
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 4, 2012