Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Gambro Lundia, FA-2019-050, Prismaflex Control Unit

   Baxter Healthcare will be upgrading the software on Prismaflex control units to reduce the frequency of communication error ...

   Waarschuwing | 11-10-2019

2. Ethicon Endo-Surgery LLC FMJR 19-058 ECHELON FLEX™ Powered Plus ENDOPATH® 60mm Stapler – 340mm shaft

   Ethicon has initiated a voluntary recall of specific product lots and kits of ECHELON FLEX ENDOPATH 60mm Staplers, were ...

   Waarschuwing | 08-10-2019

3. Merit Medical Systems, 1721504-09/20/19-004R, DTX Safedraw Kits and Meritrans DTXPlus Devices

   Vanuit de praktijk heeft Merit klachten ontvangen die erop wijzen dat de slang is losgekomen van de druppelkamer.  

   Waarschuwing | 04-10-2019

4. Convatec Limited 2019-006MA Convex Two-Piece Skin Barriers i.e. Natura

   ConvaTec has voluntarily initiated a Field Safety Corrective Action in the form of a Customer Notification for specific product ...

   Waarschuwing | 20-09-2019

5. Olympus Medical Systems, QIL 152-005, MAJ-209 SINGLE USE SUCTION VALVE

   As of today, and as a mere, additional precautionary measure, Olympus is enabled for a proper and timely replacement of the ...

   Waarschuwing | 28-08-2019

6. Baxter Healthcare, FA-2019-041, PrisMax V2 ROW

   Baxter Healthcare has identified the potential for certain PrisMax devices to develop cracks in the blood pump raceway over time ...

   Waarschuwing | 19-08-2019

7. UROMED Kurt Drews, 1505, UROMED Catheter exchange set

   Based on the information available to us, the sterilisability of the cardboard kidney trays contained in the above mentioned ...

   Waarschuwing | 15-08-2019

8. Apollo Endosurgery, Inc. - FSCA-19-001 - BIB/Orbera365 Intragastric Balloon Systems

   Deze corrigerende veiligheidsactie heeft niet betrekking op een malfunctie of defect van een product, maar op een update van de ...

   Waarschuwing | 30-07-2019

9. Rocket Medical, CUST-OCC110, Rocket® KCH foetale blaasdrain

   We hebben een klacht ontvangen dat het hulpmiddel knikt voorafgaand aan gebruik.

   Waarschuwing | 23-07-2019

10. GBUK Enteral Ltd 4328 NIAC WT-15636 - Nutricare Infant Feeding Tube

    There have been complaints relating to the outside wall of the Naso-gastric feeding tube splitting at a point of contact with the ...

    Waarschuwing | 26-06-2019