Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Arrow International LLC (Subsidiary of Teleflex Incorporated), EIF-000561, FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB

   Teleflex is initiating this voluntary FSCA for the above-mentioned products due to reports indicating an infrequent condition ...

   Waarschuwing | 08-05-2024

2. B.Braun Melsungen AG, FSCA-2024-04-23, EASYPUMP® II LT

   Tijdens onze Post Market Surveillance-activiteiten heeft de fabrikant in één geval een aanzienlijke overmatige infusie in de ...

   Waarschuwing | 07-05-2024

3. Karex Industries Sdn. Bhd., FSN-24/03, Endocavity Probe Cover

   Following the receipt of a customer complaint, and after investigations by the Legal Manufacturer, Medline has been informed that ...

   Waarschuwing | 29-04-2024

4. Medtronic MiniMed, FA1249, MiniMed 600 and 700 series insulin pump Battery Cap

   We’ve previously reached out to you about a potential issue with the battery cap on the MiniMed™ 600 series and MiniMed™ 700 ...

   Waarschuwing | 25-04-2024

5. Smiths Medical, FA2402-03, Cardinal Health Branded Monoject Syringe

   Op 20 september 2023 heeft Cardinal Health een productcorrectie voor medische hulpmiddelen uitgevaardigd voor de Monoject ...

   Waarschuwing | 15-04-2024

6. Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator

   Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.

   Waarschuwing | 04-04-2024

7. Mölnlycke Health Care AB, 2024-02(02), specific batches of the Detachable EndoRetrieval Pouch, which can be either a Single Packed device or included as a component in identified Mölnlycke® Procedure trays

   The device is used to contain and extract specimens during laparoscopie surgery. The mechanism of the listed device operates in a ...

   Waarschuwing | 03-04-2024

8. 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

9. Epic Systems Corporation, SLG 8588391, Regulated Decision Support Framework

   In a system configured as described below, when the following workflow is performed, the system clears the Calculated Administer ...

   Waarschuwing | 15-03-2024

10. 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