Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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 ...

   Waarschuwing | 26-03-2024

2. 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.

   Waarschuwing | 25-03-2024

3. Convatec Ltd, TW-1832110, CarboFlex®

   Convatec Inc voert een vrijwillige corrigerende maatregel (verwijdering) uit voor de veiligheid van medische hulpmiddelen ...

   Waarschuwing | 25-03-2024

4. 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 ...

   Waarschuwing | 25-03-2024

5. 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 ...

   Waarschuwing | 18-03-2024

6. 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 ...

   Waarschuwing | 18-03-2024

7. 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. ...

   Waarschuwing | 14-03-2024

8. 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 ...

   Waarschuwing | 07-03-2024

9. 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 ...

   Waarschuwing | 05-03-2024

10. 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 ...

    Waarschuwing | 22-02-2024