Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus Medical Systems Corporation, QIL FY24-EMEA-22-FY24-OMSC-08-BF Burnt Distal End, Flexible video bronchoscope, reusable

   There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the ...

   Waarschuwing | 31-10-2023

2. Creganna Medical, TIP-23-001, GORE TIPS Set

   Gore has identified three lots of GORE TIPS Set devices that may be labeled with the incorrect expiration date. GORE TIPS Set ...

   Waarschuwing | 13-10-2023

3. Siemens Shenzhen Magnetic Resonance Ltd., MR078/23/S, Headband of the over-ear headphones

   This letter is to inform you about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within ...

   Waarschuwing | 06-10-2023

4. Seffiline S.R.L., SEFFIHAIR 3.1-SEFFICARE 3.1-SEFFIGYN 3.1-SEFFILLER 3.1 Seffiline S.r.l.

   During the assembly of the kits, two transfers for luerlock syringes supplied by a supplier other than the one qualified by ...

   Waarschuwing | 03-10-2023

5. Olympus Medical Systems Corporation, Flexible video bronchoscope reusable

   As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal ...

   Waarschuwing | 09-08-2023

6. PAUL HARTMANN AG, 20230731DrapesProtectPlus, Protect Plus Patient drapes CombiSet, Foliodrape

   HARTMANN received customer complaints mentioning loose fibers release.

   Waarschuwing | 07-08-2023

7. Ameco Medical Industries, VIG-25-2023-FC01, Amecath Short Term Haemodialysis Catheter Kit

   Inappropriate Catheter Fixation. Using “Unifix Catheter Tube Fixation Adhesive” instead of wing suturing will prevent the ...

   Waarschuwing | 27-07-2023

8. Tornier INC, RA2023-3322296, Aequalis Flex Revive

   Stryker has identified a nonconformance in two specific lots of Aequalis Flex Revive Assembly Screws.

   Waarschuwing | 25-07-2023

9. Mölnlycke Health Care AB, FSN-2023-06(03), Emergency Chest Re-opening Pack, ANZ Emergency Chest Re-opening Pack, NZ Emergency Chest Re-opening Pack, Acute thorax tray, Thorax trauma tray

   Mölnlycke has recently been informed by the Legal Manufacturer Blink Medical, that they are performing a recall on products ...

   Waarschuwing | 20-07-2023

10. FUJIFILM Irvine Scientific Inc, FSN-FSCA2023-002, Oil for Embryo Culture

    Per the delivery note on your order, your facility should have received lot 0000011349; however, your facility received lot ...

    Waarschuwing | 20-07-2023