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Sources: EU EUDAMED, US FDA
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KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·April 15, 2020
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·April 15, 2020
Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
FDA Enforcement
Class I
·Terminated·B. Braun Medical, Inc.·July 25, 2012
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·October 3, 2012
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 . Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·September 26, 2012
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 Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·December 18, 2013
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 12, 2020
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·February 12, 2020
Endura No-React Dural Substitute 6 cm x 10 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No React Dural Substitute 10 cm x 12 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
Endura No-React Dural Substitute 2 cm x 10 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No-React Dural Substitute 4 cm X 4 cm.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
EnDura No-React Dural Substitute 5 cm x 6 cm
FDA Recall
Terminated
·Integra LifeSciences Corp.·May 4, 2007
EnDura No-React Dural Substitute 12 cm Diameter
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007
InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.
FDA Recall
Terminated
·Abbott Spine·Product code MNI·March 24, 2008
PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.
FDA Recall
Terminated
·Abbott Spine·Product code MNI·March 24, 2008
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FRN·March 23, 2012
Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null lymphocytes.
FDA Recall
Terminated
·Sigma-Aldrich Mfg LLC·Product code JCF·December 8, 2009
Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.
FDA Recall
Terminated
·Sigma-Aldrich Mfg LLC·Product code JCF·September 4, 2009
PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress.
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code DXZ·June 30, 2010