SUMMARY OF FIELD SAFETY NOTIFICATIONS / MARCH 2024
USER INFORMATION
Articulating burr Ø 4mm / manufacturer Richard Wolf GmbH, Germania
Ref. ANMDMR: 301.578/24
USER INFORMATION
Quo-Lab A1C Test Kit; PocketChem™A1c bA1c Test Kit / manufacturer EKF-diagnostic GmbH, Germania
Ref. ANMDMR: 301.579/24
USER INFORMATION
Kituri LVAS HeartMate 3™/ manufacturer Thoratec Corporation, SUA
Ref. ANMDMR: 301.608/24
USER INFORMATION
High Flow Insufflation Unit UHI-4 / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 301.609/24
PRODUCT RECALL
Canule/ manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 301.626/24
PRODUCT RECALL
Leukoplast® Compress Cotton Gauze T17 10×10 cm; Leukoplast® Compress Viskers Gauze T17 18×20 cm / manufacturer BSN Medical GmbH, Germania
Ref. ANMDMR: 301.644/24
USER INFORMATION
EQUASHIELD® Closed System Transfer Device, Spike Tubing / manufacturer Equashield Medical Ltd, Israel
Ref. ANMDMR: 301.645/24
USER INFORMATION (PRODUSE FURATE)
AltoSa-XL-Gemini Balloon Catheter / manufacturer Andratec GmbH, Germania
Ref. ANMDMR: 301.646/24
USER INFORMATION
EZ2® Connect MDx / manufacturer QIAGEN GmbH, Germania
Ref. ANMDMR: 301.647/24
PRODUCT RECALL
Radius plates, template for radius plate / manufacturer Medartis AG, Elvetia
Ref. ANMDMR: 301.682/24
USER INFORMATION
Triangle Tip Electrosurgical Knife / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 301.683/24
PRODUCT RECALL
Dilatator ureteral / manufacturer Coloplast A/S, Danemarca
Ref. ANMDMR: 301.684/24
USER INFORMATION
Alinity m System / manufacturer Abbott Molecular, Inc., SUA
Ref. ANMDMR: 301.702/24
PRODUCT RECALL
EXPO™ Angiographic Catheter / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 301.706/24
USER INFORMATION
Experience Mini Metal Rhodium / manufacturer GC Orthodontics Europe GmbH, Germania
Ref. ANMDMR: 301.707/24
USER INFORMATION
Sensor box of Xenios console / manufacturer XENIOS AG, Germania
Ref. ANMDMR: 301.733/24
USER INFORMATION
Ventilators in the EVE family / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 301.735/24
USER INFORMATION
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch / manufacturer Synovis Life Technologies Inc. (St. Paul) – a subsidiary of Baxter International Inc., SUA
Ref. ANMDMR: 301.736/24
USER INFORMATION
Twin Tube, Twin Tube Probenschlauch / manufacturer Vyaire Medical GmbH, Germania
Ref. ANMDMR: 301.738/24
PRODUCT RECALL
K-wire / manufacturer Medartis AG, Elvetia
Ref. ANMDMR: 301.785/24
USER INFORMATION
ORBIS Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 301.786/24
USER INFORMATION
X-ray system / manufacturer Siemens Healthineers GmbH Advanced Therapies, Germania
Ref. ANMDMR: 301.810/24
USER INFORMATION
Fiolă de calibrare BD BACTEC™MicroMGIT™ / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 301.851/24
PRODUCT RECALL
LASER Application Instrument, 23 cm, LEUNIG-GREVERS LASER Application / manufacturer Karl Storz SE & Co. KG, Germania
Ref. ANMDMR: 301.852/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.