{"id":10955,"date":"2025-03-01T08:00:29","date_gmt":"2025-03-01T05:00:29","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=10955"},"modified":"2025-08-04T08:26:19","modified_gmt":"2025-08-04T05:26:19","slug":"sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2024","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/sumarul-notificarilor-in-materie-de-siguranta-in-teren-martie-2024\/","title":{"rendered":"Summary of field safety notifications \/ MARCH 2024"},"content":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ MARCH 2024<\/strong><\/p>\n

USER INFORMATION <\/strong>
\nArticulating burr \u00d8 4mm \/ manufacturer Richard Wolf GmbH, Germania
\nRef. ANMDMR: 301.578\/24 <\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nQuo-Lab A1C Test Kit; PocketChem\u2122A1c bA1c Test Kit \/ manufacturer EKF-diagnostic GmbH, Germania
\nRef. ANMDMR: 301.579\/24 <\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nKituri LVAS HeartMate 3\u2122\/ manufacturer Thoratec Corporation, SUA
\nRef. ANMDMR: 301.608\/24 <\/span><\/a><\/p>\n

USER INFORMATION <\/strong>
\nHigh Flow Insufflation Unit UHI-4 \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 301.609\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nCanule\/ manufacturer Medtronic Inc., SUA
\nRef. ANMDMR: 301.626\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLeukoplast\u00ae Compress Cotton Gauze T17 10×10 cm; Leukoplast\u00ae Compress Viskers Gauze T17 18×20 cm \/ manufacturer BSN Medical GmbH, Germania
\nRef. ANMDMR: 301.644\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEQUASHIELD\u00ae Closed System Transfer Device, Spike Tubing \/ manufacturer Equashield Medical Ltd, Israel
\nRef. ANMDMR: 301.645\/24 <\/span><\/a><\/p>\n

USER INFORMATION (PRODUSE FURATE)<\/strong>
\nAltoSa-XL-Gemini Balloon Catheter \/ manufacturer Andratec GmbH, Germania
\nRef. ANMDMR: 301.646\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nEZ2\u00ae Connect MDx \/ manufacturer QIAGEN GmbH, Germania
\nRef. ANMDMR: 301.647\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nRadius plates, template for radius plate \/ manufacturer Medartis AG, Elvetia
\nRef. ANMDMR: 301.682\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTriangle Tip Electrosurgical Knife \/ manufacturer Olympus Medical Systems Corporation, Japonia
\nRef. ANMDMR: 301.683\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nDilatator ureteral \/ manufacturer Coloplast A\/S, Danemarca
\nRef. ANMDMR: 301.684\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nAlinity m System \/ manufacturer Abbott Molecular, Inc., SUA
\nRef. ANMDMR: 301.702\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nEXPO\u2122 Angiographic Catheter \/ manufacturer Boston Scientific Corporation, SUA
\nRef. ANMDMR: 301.706\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nExperience Mini Metal Rhodium \/ manufacturer GC Orthodontics Europe GmbH, Germania
\nRef. ANMDMR: 301.707\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nSensor box of Xenios console \/ manufacturer XENIOS AG, Germania
\nRef. ANMDMR: 301.733\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nVentilators in the EVE family \/ manufacturer Fritz Stephan GmbH, Germania
\nRef. ANMDMR: 301.735\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nPERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch \/ manufacturer Synovis Life Technologies Inc. (St. Paul) – a subsidiary of Baxter International Inc., SUA
\nRef. ANMDMR: 301.736\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nTwin Tube, Twin Tube Probenschlauch \/ manufacturer Vyaire Medical GmbH, Germania
\nRef. ANMDMR: 301.738\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nK-wire \/ manufacturer Medartis AG, Elvetia
\nRef. ANMDMR: 301.785\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nORBIS Medication \/ manufacturer DH Healthcare GmbH, Germania
\nRef. ANMDMR: 301.786\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nX-ray system \/ manufacturer Siemens Healthineers GmbH Advanced Therapies, Germania
\nRef. ANMDMR: 301.810\/24 <\/span><\/a><\/p>\n

USER INFORMATION<\/strong>
\nFiol\u0103 de calibrare BD BACTEC\u2122MicroMGIT\u2122 \/ manufacturer Becton, Dickinson and Company, SUA
\nRef. ANMDMR: 301.851\/24 <\/span><\/a><\/p>\n

PRODUCT RECALL<\/strong>
\nLASER Application Instrument, 23 cm, LEUNIG-GREVERS LASER Application \/ manufacturer Karl Storz SE & Co. KG, Germania
\nRef. ANMDMR: 301.852\/24 <\/span><\/a><\/p>\n

Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

SUMMARY OF FIELD SAFETY NOTIFICATIONS \/ MARCH 2024 USER INFORMATION Articulating burr \u00d8 4mm \/ manufacturer Richard Wolf GmbH, Germania […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10955","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=10955"}],"version-history":[{"count":2,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10955\/revisions"}],"predecessor-version":[{"id":10957,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/10955\/revisions\/10957"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=10955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=10955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=10955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}