Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
538 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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W. L. Gore & Associates, Inc. Medical Products Division, 2017233.09.15.2022.001-R, GORE® CARDIOFORM ASD Occluder
Gore has identified one batch of GORE® CARDIOFORM ASD Occluder devices that was incorrectly released following a documented ...
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GELITA MEDICAL GmbH, FSN-CR-22-006, GELITA-SPON STANDARD, GELITA-SPON RAPID3, GELITA ENT X-BLOD, GELITA ENT X-DENSE, GELITA ENT X-PAND, GELITA ENT X-PASTE, GELITA-SPON POWDER
In re-testing ordered by the manufacturer, the endotoxin concentration of the product in some samples has been measured above the ...
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Atrium Medical Corporation 3011175548-02/25/2022-001-C - Advanta V12 Covered Stent System
Atrium/Getinge is initiating a voluntary Medical Device Field Correction for the Advanta V12 Covered Stent System due to an ...
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LeMaitre Vascular, CAPA 2022-001-NL, AlboGraft Polyester Vascular Graft
LeMaitre trekt bepaalde AlboGraft-apparaten terug en ruilt ze om vanwege een wijziging in de wettelijke status.
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Medtronic FA1197 - Abre™ Venous Self-expanding Stent System
Medtronic heeft in overleg met een onafhankelijk artsenpanel geconcludeerd dat enige aanpassing van het gebruik kan helpen om het ...
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Bard Access Systems Inc, FSN-MDS-21-4027, Groshong Catheters
BD verstuurt een adviserend veiligheidsbericht voor specifieke partijen Groshong-katheterproducten.
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VENITI, Inc., FSN-92672766-FA, VICI VENOUS STENT™ and VICI RDS™ Stent Systems
Boston Scientific Corporation (BSC) initieert vrijwillig een wereldwijde terugroep actie van alle lotnummers/batches van de VICI ...
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Bolton Medical Inc., FSN-2247858-02-22-2021-001C, RelayPlus and Relay 85
Urgent Field Safety Notice RelayPlus and Relay 85.
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Maquet Cardiopulmonary GmbH, FSN-FSCA-2020-07-31, Heater Unit HU 35, ROTAFLOW System and ROTAFLOW System with ROTAFLOW ICU Console
Due to the update of the IEC Standard 60601-1-2 for Electromagnetic compatibility (EMC) to its 4th edition, the medical devices ...
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Endologix Inc, FSN-FS-0012, Ovation Abdominal Stent Graft System Platform
This FSN is specific to the following Ovation iX Abdominal Stent Graft Systems, and impacts all lot/serial numbers: TV-AB2080-I, ...