132 results
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12ms
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Sources: EU EUDAMED, US FDA
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Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·November 21, 2012
Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes
FDA Recall
Terminated
·Remel Inc·Product code JTN·April 9, 2013
Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·April 9, 2013
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·November 21, 2013
Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·April 9, 2013
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
FDA Recall
Terminated
·Remel Inc·Product code JTN·August 21, 2012
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes
FDA Recall
Terminated
·Remel Inc·Product code JTN·April 9, 2013
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
FDA Recall
Terminated
·Remel Inc·Product code JTN·March 25, 2013
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
FDA Recall
Terminated
·Remel Inc·Product code JTN·February 18, 2014
REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.
FDA Recall
Terminated
·Remel, Inc.·Product code JTN·December 5, 2002
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall
Terminated
·Remel Inc·Product code JTN·November 6, 2015
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).
FDA Recall
Terminated
·Remel Inc·Product code JTN·August 21, 2012
BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTN·February 19, 2007
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
FDA Recall
Terminated
·Remel Inc·Product code JTN·June 18, 2021
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HSB·December 20, 2017
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HSB·December 20, 2017
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
FDA Recall
Terminated
·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
FDA Recall
Terminated
·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021