Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
465 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Coloplast A/S, FSCA_20240223_Ureteral dilator, Ureteral Dilator (Ch/Fr 12-14, length 48 cm)
In de faciliteit van Coloplast is bij sommige urethraledilatorproducten een mogelijk steriliteitsprobleem ontdekt. Dit probleem ...
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NRT X-Ray A/S, PR20230929-02, Celex
The event made the Celex system move without being under control of the operator. This may put patients or operators at risk.
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Convatec Ltd, TW-1832110, CarboFlex®
Convatec Inc voert een vrijwillige corrigerende maatregel (verwijdering) uit voor de veiligheid van medische hulpmiddelen ...
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LABORATOIRES VIVACY, FSCA24-001, STYLAGE M LIDOCAINE
A syringe of STYLAGE XL Lidocaine is inserted in the packaging of STYLAGE M lidocaine. The labelling of the box, labelling of the ...
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Emery Enterprise, Inc dba ITL Dental, EU FSCA 1-30-2024, ITL Dental Dental Implant System
During a MDSAP/EU MDR 2017/745 audit a template with the CE mark was put on 7 devices to be shipped - it was discovered, and the ...
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Applied Medical Resources Corporation, 2027111-01/26/24-001-R, CA500, Epix UNIVERSAL CLIP APPLIER 3/BX
Applied Medical is conducting a Field Safety Corrective Action of specific lot numbers of its Epix® Universal Clip Applier due to ...
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Olympus Medical Systems Corporation, QIL FY24-EMEA-40-FY24-OMSC-36, Single Use Electrosurgical Knife
Olympus's investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Tot onze spijt moeten wij u mededelen dat Intuitive zich ervan bewust is geworden dat bepaalde partijen van de volgende producten ...
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SYNOVIS LIFE TECHNOLOGIES, INC. (A SUBSIDIARY OF BAXTER INTERNATIONAL INC.), FA-2024-010, SPERI-GUARD; SUPPLE PERI-GUARD
On March 7, 2022, Baxter implemented labeling changes on CE-marked Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch ...
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Boston Scientific Corporation, 97156074-FA, iSLEEVE™ Expandabel Introducer Set
Boston Scientific voert een verwijdering uit van specifieke partijen van de iSLEEVETM 14F expandeerbare inbrengset wegens ...