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    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

    Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LRS·April 21, 2026

    Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·August 6, 2025

    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023

    VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023

    Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 10, 2025

    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

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics·Product code PCH·February 22, 2019

    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