31 results
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13ms
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Sources: EU EUDAMED, US FDA
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·April 11, 2018
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·October 30, 2013
Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
FDA Recall
Terminated
·Astora·Product code PAH·October 26, 2015
Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
FDA Recall
Terminated
·Pioneer Surgical Technology·Product code MVH·July 29, 2005
Kit BD Max Enteric Viral Panel EU Catalog # 443985
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
FDA Recall
Terminated
·Luminex Corporation·Product code PCH·May 8, 2018
Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
Kit EXT Enteric Bacterial Panel; Catalog # 443812
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PCH·July 17, 2019
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PCH·March 6, 2019
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
FDA Recall
Terminated
·Nanosphere, Inc.·Product code PCH·October 10, 2013
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PCH·August 8, 2019