40 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
FDA Recall
Open, Classified
·Biomerieux Inc·Product code LQL·November 9, 2022
VITEK2 GP-ID, REF 21342 IVD
FDA Recall
Terminated
·Biomerieux Inc·Product code LQL·October 11, 2017
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Recall
Open, Classified
·Oxoid Australia Pty Limited 20 Dlgleish St South Australia Australia·Product code LQL·March 3, 2026
The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LQL·March 23, 2018
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
FDA Recall
Terminated
·Biomerieux Inc·Product code LQL·August 25, 2017
VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
FDA Recall
Open, Classified
·Biomerieux Inc·Product code LQL·November 9, 2022
VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code LQL·April 20, 2017
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Recall
Open, Classified
·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
FDA Recall
Terminated
·I-Flow Corporation·Product code FMF·August 1, 2008
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Recall
Terminated
·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FPA·June 17, 2024
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump.
FDA Recall
Terminated
·I-Flow Corporation·Product code FMF·August 1, 2008
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQY·September 29, 2009
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQY·September 29, 2009
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQY·September 29, 2009
Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQY·September 29, 2009
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OXQ·March 9, 2026
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
FDA Recall
Open, Classified
·LSL Healthcare Inc.·Product code OIB·March 9, 2026