Bfarm recall database Product group Active implantable medical devices Reference 00830/10. 30 PDF, 106KB, File does not meet accessibility Product group Medical instruments for use in humans - bone surgery Reference 02414/13. The manufacturer Abbott Medical Optics Inc. The customers were requested to discontinue use, immediately, and discard the affected products. The corresponding forms can be found at Reports and corrective actions. 26 PDF, Product group Non-active implants - special implants Reference 07364/12. The integrity of the sterile package may be compromised. 26 PDF, 59KB, File does not meet accessibility standards All topics at a glance Reporting risks. The Farco-Pharma GmbH recalls one lot of Endosgel 11 ml from the market. 2010 concerning the revision rate data of the ASR System. -Nr. . The recall is based on a wrong diopter labelling. Database description for AMIce Terms of Substances; Tasks of the BfArM. The company Bausch & Lomb Inc. Lot Recall of Endosgel 11 ml, Farco-Pharma , Download_VeroeffentlichtAm_EN 2011. Batch recall of Helioseal Clear, Ivoclar Vivadent AG, Download_VeroeffentlichtAm_EN 2016. DHS/DCS Screw: The company SYNTHES has informed about the recall of several lots. Recall for PillCam Express Video Capsule Delivery Device, Given Imaging , Download_VeroeffentlichtAm_EN 2011. Recall of Nova Biomedical for Nova StatStrip Glucose Test-Strips (Lot-No. Cook recalls the device Zenith due to a stent-graft loading problem. 18 PDF, 373KB, File does not meet accessibility standards All topics at a glance Reporting risks Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. / USA has initiated a recall of Linx Reflux Management System Esophagus Sizing tool LSS-2 with the scope of the lot numbers #4150 or lower. 57 database, the data on the QPPV are updated. Language: German. BfArM - Federal Institute for Drugs and Medical Devices Product group Non-active implants Reference 04427/11. Customers were informed to discard the affected batch. 950501306) due to the potential for the impactor to become fixed on the tibial tray implant when impacting the tray into position during surgery. To overview: Operating the system; System re The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. Reference Number: mdprc 014 06 22 000: Date submitted: 6/13/2022: Manufacturer: Lohmann & Rauscher: Device Type: Gauze compresses with x-ray thread: BfArM: Source Ref. To overview: Operating the system; System requirements; Further tasks Product group Non-active implants - special implants Reference 05658/12. and the distributor Dr. You can book the flat fees via our online system. Database description for AMIce Terms of The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited. Batch recall of GENESIS Trocar Pin, Smith & Nephew Inc. Boston Scientific recalls certain lots of Model 7060 ACUITY Universal Cutter. BfArM - Federal Institute for Drugs and Medical Devices Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. Recall of a limited number AMIce contains the approval data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer Protection and Food Safety). Boston Scientific recalls all Guider Softtip™ XF Guide Catheters from the market, whose packaging is not yet labelled with a warning about safe storage (see also BfArM publication of 22. Thus, this information helps other patients but also e. 08 PDF, 75KB, File does not meet accessibility standards All topics at a glance Reporting risks To overview: Public databases; Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. Affected products belong to the following Lot numbers: 118W, 119W and 11XW. 24 PDF, 56KB, File does not meet accessibility standards All topics at a glance Reporting risks Product group Medical instruments for use in humans Reference 04938/11. Since the MDR comes applicable on 26. For further information as well as details concerning the device please see the enclosed Advisory Notice of the manufacturer. The customers were informed about the problem and how to avoid it. Product group In-vitro diagnostics - equipment / products for clinical chemistry Reference 08718/15. This may cause either difficulties in impacting the inlay or impede stable fixation of the inlay. 02. Recall for AB 5000 Console, ABIOMED , Download_VeroeffentlichtAm_EN 2010. Discarded products will be progressively replaced by Regen Lab SFDA urges all healthcare providers that have devices subjected to this safety alert to contact the company. 11. , Download_VeroeffentlichtAm_EN 2016. To overview: Operating the system; System re Information letter on Vitamin B12-ratiopharm N solution for injection: Recall due to visible particles. Product group Medical electronics / Electromedical devices Reference 01390/11. For Additional information please see the Advisory Notice published on 26. Size: 56,185 (status 10/2024) Update: daily The company GYNECARE is conducting a global product recall of the connector cable component of the GYNECARE VERSAPOINT Bipolar Electrosurgery System. A product recall has been initiated concerning polyaxial screws SX807T MACS TL HMA 12 x 34 mm produced by Aesculap AG & Co. DePuy recalls the DePuy SIGMA HP FB TIBIAL TRAY IMPACTOR (Model no. To overview: Tasks of the BfArM; Clinical investigations and perfor Database description for AMIce Terms of Substances; Tasks of the BfArM. 24 PDF, 56KB, File does not meet accessibility standards All topics at a glance Reporting risks Olympus has issued a Field Safety Notice concerning a recall of Working Elements for Resectoscopes (Art. SFDA urges all healthcare providers that have devices subjected to this safety alert to contact the company. Recall for the Linx Reflux European Database on Adverse Drug Reaction Reports; Risk Management Plans (RMP) responsible for placing medical devices on the market for the first time are obliged to report certain incidents and recalls to the BfArM or the PEI. Philips Healthcare has issued a Field Safety Notice concerning a recall of a limited number of the automated external defibrillators (AEDs) HeartStart FRx 861304, HeartStart HS1 M5066A and HeartStart Home M5068A, manufactured by Philips in March 2010. if the urgent medical need cannot be met otherwise, and from the point of Product group Non-active implants - bone surgery Reference 05375/12. 2 cartridges. bfarm. Advisory Notice is only available in German language. Size: 12,013 (status 10/2024) Update Here you will find a compilation of websites on which the EU Commission provides information on the European regulations 2017/745 (MDR) and 2017 /746 (IVDR), on current topics in the European medical device sector, and specifically on the European medical device database EUDAMED. 11 PDF, 89KB, File does not meet accessibility Integra has issued a Field Safety Notice concerning a recall of the Luxtec UltraLite Pro headlight models AX2000BIF, AX2100BIF, AX1375BIF, AX1375BIFSL, AX1385BIF, AX1385BIFSL, 001380LX, 001380LXSL, 001328 or of models received a Mark II module replacement, manufactured during the period of March 2009 through May 31, 2011. 6 % and i-Visc 2. For medicinal products for which the Variation Regulation ( EC ) No. 28 PDF, 122KB, File is accessible Information letter on Vitamin B12-ratiopharm N solution for injection: Recall due to visible particles. Due to insufficient material strenght the distal tip may break. 08. Trigen HFN Nail: The company Smith & Nephew has informed about a recall of several lots of these products. Submissions without a “ Bescheidmaske ” will be rejected unprocessed. 12 PDF, 336KB, Product group Non-active implants Reference 04698/10. Recall of the device Zenith from Cook , Download_VeroeffentlichtAm_EN 2007. Recall of one lot of the Dilatator, De Bakey, Gebrüder Martin GmbH, Product group Medical electronics / Electromedical devices Reference 01824/06. Active substance: Vitamine B12 Recall of the Anspach single-use cutting burrs from Anspach Effort Inc. To overview: Operating the system; System re This database contains Medical Device Recalls classified since November 2002. As part of the merger of DIMDI with BfArM, contents of this website have been moved to the website www. 06. 1234/2008 does not apply, but for which the national Variation Regulation of section 29 AMG continues to apply, a notification of variation pursuant to section 29 AMG (“Änderungsanzeige”) must be submitted. 10. The products manufactured by Fluoron GmbH are withdrawn, because the firm received reports about postoperative opacifications of the silicone oil tamponades and patient`s reduced visual function. The affected lot has occasionally been mixed up with the smaller Viscoglide 1. The products had been marked with size 26 mm instead of 34 mm. The manufacturer OptiMed GmbH recalls one lot of the BigLumen Aspiration catheter for intravascular treatment from the market due to mislabeling. To overview: Operating the system; System requirements; Further tasks Product group In-vitro diagnostics Reference 00592/10. Intramedullary skeletal kinetic distractor, ISKD: The company ORTHOFIX has informed about the recall of these products. Covidien informed that the lot numbers P0A0021 and P0A0723 (see Annex) were not delivered in Europe. Recall for DePuy ASR™ Articular Surface Replacement Recall of the Temporary Pervenous Pacing Leads – QSTIM from Biosense Webster , Download_VeroeffentlichtAm_EN 2006. BRAHMS AG Henningsdorf: Complete recall of test-kit PCT (Procalcitonin) direct. 16 PDF, 378KB, File does not meet accessibility standards Product group Injections / Infusions / Transfusions / Dialysis Reference 02373/07. 08 PDF, 54KB, File does not meet accessibility BfArM. The action was initiated because of a manufacturing failure in such a manner, that one of the distal locking screw holes was drilled with an incorrect trajectory, which may extend time of surgery. To If you have a specific time period or a safety issue type in mind (e. : WA22066A, WA22067A, WA22366A, WA22367A) due to a probably impaired insulation function and the hazard of sparking during activation of HF energy. You can find device corrective actions, including recalls, on the German market from the Field Corrective Actions database on German competent authority BfArM’s website. Reference Number: mdprc 002 11 22 001: Date submitted: 11/15/2022: Manufacturer: Regen Lab SA: Device Type: A-CP Kits Family, RegenKit-BCT Family: Description: Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells: Medical Device Identifier: Refer to “Details on Affected devices” in the Here you will find answers to frequently asked questions about the database. BfArM update action: Please maintain the stop use and discard all affected products previously quarantined. 14. Active substance: Vitamine B12 Medical devices are products with a medical purpose, intended by the manufacturer for human use. Recall for GastroSoft biliary-stents, OptiMed , Download_VeroeffentlichtAm_EN Product group In-vitro diagnostics Reference 00592/10. 01. 2021, the reporting of serious adverse events (SAEs) and device deficiencies (DDs) must be carried out in accordance with the European Regulation 2017/745 (MDR) in conjunction with the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must BfArM website: Reporting of (suspected) serious incidents, recalls and serious adverse events (SAEs). Database descriptions AMIce (BfArM website) Further medicinal product information Medical Device Recall of MENTOR® Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Customers were informed to discard the affected batch. 0 %, i-Medical Ophthalmic International Heidelberg GmbH, Download_VeroeffentlichtAm_EN 2016. 15 Product group Active implantable medical devices Reference 00830/10. Lot recall of HbA1c 501 Test Cartridges, HemoCue AB WaveLight GmbH (former Acrimed GmbH ) informs individual users about a lot recall of the acrylic intraocular lens Acriflex 47CSE (BfArM case-number 0465/06) and 48CSE (BfArM case-number 0498/06) respectively due to diopter mislabelling on the packaging. de is a cooperative project of the German regulatory authorities – Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)), the Paul-Ehrlich-Institut (PEI), the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)) and the Robert Product group Medical electronics / Electromedical devices Reference 02003/10. 12 PDF, 157KB, File does not meet accessibility standards All topics at a glance Reporting risks Product group ophthalmological technology Reference 01733/08. The BfArM may allow in exceptional circumstances market access of medical devices, which have not undergone a regular conformity assessment procedure for CE marking, in Germany for a limited period of time, if this is in the interest of health protection. Thereby, the affected electrodes are no more compatible with the Nihon Kohden defibrillator models TEC-55321, TEC-5531, Biomedica Medizinprodukte GmbH has issued an information about a product recall regarding the device BI-20052 Endothelin ELISA, Lot-Number 901C. In addition, the Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. Lot recall of Devon Light Glove, Medtronic , Download_VeroeffentlichtAm_EN 2017. Lot recall of GyneFix, Gynlameda GmbH, Download_VeroeffentlichtAm_EN 2017. The manufacturer Mentor informs about a recall of multiple lots of Perthese and Mentor implants as some units were inadvertently labelled with an incorrect expiration date. Recall of ECO process in Miele / Olympus ETD washer-disinfectors , Further contents of DMIDS Notification of Incidents and SAE with Medical Devices. URGENT: FIELD SAFETY NOTICE . The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. The manufacturer Aesculap AG Tuttlingen recalls his medical device S4 FW258R K-Wire-Guidung Instrument for Set S4 SC. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of If problems occur with medical devices, the manufacturer or the person who assembles the systems or procedure packs (system and procedure pack producer (SPPP)) may have to initiate a Field Safety Corrective Action (FSCA). Incidents and serious adverse events (SAE) in clinical trials with medical devices must be notified to BfArM and/or PEI. Unlike medicinal products, which have a pharmacological, immunological or metabolic action, the main intended action of medical devices is primarily achieved by physical means, for example. Recall for Quatrix® Aspheric Evolutive Yellow IOL, Croma Pharma , Download_VeroeffentlichtAm_EN 2009. Bund. Dear Valued Customer, Descriptions of the different types of recall actions is available at: About Australian recall actions. Respironics Deutschland GmbH informs about a recall of the device Philips NM3 Monitor. SURGIFLO Hemostatic Matrix Kit: The company ETHICON has informed about a lot recall of these products. Product group In-vitro diagnostics - immunological products Reference 04622/11. initiated a recall of its Sequoia Oxymatic OM-311 and OM-312 electronic oxygen conservers manufactured in December 2004 and January 2005. Number: 08806/22: SFDA Comments: SFDA urges all healthcare providers that have devices subjected to this safety alert to contact the company. Recall of the device Philips NM3 Monitor, Respironics Deutschland GmbH, Download_VeroeffentlichtAm_EN 2011. Customers were advised to discard the product. Size: 56,185 (status 10/2024) Update: daily Recall of PO830SU / PO831SU / PO833SU, Aesculap AG, Download_VeroeffentlichtAm_EN 2016. There is the potential for the plastic tips on the drive shaft of the motors to come off the shaft and cause the blade to stop oscillating. BfArM - Federal Institute for Drugs and Medical Devices Navigation and service The marketing authorisation holder Pharma Swiss Česká republika s. The manufacturer Medicel AG, Switzerland, informs about the recall of Viscoject Cartridge Sets LP604240M (lot 047104). 8 cartridges instead of the Viscoglide 2. Recall for BigLumen Aspiration catheter, OptiMed , Download_VeroeffentlichtAm_EN 2008. BfArM - Federal Institute for Drugs and Medical Devices Product group In-vitro diagnostics Reference 01212/10. The European Database on Adverse Drug Reaction Reports; Risk Management Plans Tasks of the BfArM. The product bottels might be wrongly labelled on the back side. The english advisory notice is not available yet. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all batches of Emerade® pre-filled pens are recalled on patient level. 16 PDF, 378KB, File does not meet accessibility standards Product group Active implantable medical devices Reference 04855/10. The text of the product information is only to be inserted in Advanced Bionics recalls its of Implantable Cochlear Stimulators HiRes90K due to possible malfunction by reason of elevated level of moisture inside the casing of implants. is conducting a recall of several serial numbers of the intraocular lens “SENSAR Foldable IOL with OptiEdge”. AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI. The Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. The recall only of a few affected lenses is performed in Italy (5) and Greece (1) for Acriflex 47CSE The database is part of the German database-supported medical devices information and database system. 06 PDF, Recall of Megro for Ratiomed Troponin I (Art. e. Recall for GastroSoft biliary-stents, OptiMed , Download_VeroeffentlichtAm_EN Batch recall of Helioseal Clear, Ivoclar Vivadent AG, Download_VeroeffentlichtAm_EN 2016. European Database on Adverse Drug Reaction Reports; Risk Management Tasks of the BfArM. The device was not delivered to the German market. Product group General equipment for medical treatment Reference 03000/11. o. Recall actions are published on the SARA database two business days after the TGA sends the agreement letter to the Responsible Entity (the person The manufacturer Serumwerk Bernburg Vertriebs GmbH recalls two additional lots of the SN connector, article 1703 (see BfArM case number 3257/09). 17 Recall of SONNET Mini Battery Pack Cable, MED-EL Elektromedizinische Geräte GmbH, Download_VeroeffentlichtAm_EN 2016. Included therein is mainly administrative data and further data relevant to notification. MDR implementation date. 04 PDF, 84KB, File does Product group ophthalmological technology Reference 02334/08. Here you will find a compilation of websites on which the EU Commission provides information on the European regulations 2017/745 (MDR) and 2017 /746 (IVDR), on current topics in the European medical device sector, and specifically on the European medical device database EUDAMED. Recall for Nova StatStrip Glucose Test-Strips, Nova Biomedical , Download_VeroeffentlichtAm_EN 2010. The manufacturer Fresenius recalls several lot numbers of the peritoneal dialysis patient connectors PD Night Vario Plus Set, PD Night Vario Plus Paed Set and PD-Paed System. ConMed Corporation has issued a Field Safety Notice concerning a recall of lot 1010194 of R2 Multifunction Electrodes with catalog No. Recall of consoles of implantable AB 5000 VAS of ABIOMED Inc. PharmNet. To overview: Public databases; Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. The manufacturer Micro-Tech has conducted a recall of several batches of the product Spiked Biopsy Forceps. Recall of gabControl Strep A Test Cards, gabmed , Download_VeroeffentlichtAm_EN 2012. BfArM - Federal Institute for Drugs and Medical Devices. Reports and corrective actions. 02 Product group Non-active implants - special implants Reference 01950/17 Batch / lot recall of i-Visc 1. The pharmaceutical manufacturer is sending out information to healthcare professionals on a product recall that is leading to shortages in the EU. 22 PDF, 148KB, File does not meet accessibility standards All topics at a glance Recall of Bio-Rad Laboratories for Leptospira Serology Kit, lot 8C2034, because of a problem with the antigen stability leading to false negative results. These devices may have been manufactured with shot size measurements that are below the manufacturing specifications and need to be recalibrated. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. has issued an information concerning a recall of the Cool-tip™ Ablation System. OptiMed Medizinische Instrumente GmbH is conducting a recall for 15 specimens of biliary-stents (GastroSoft), due to a possible non-sterility because of packaging-deficits. The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited. 05. Database description. The incident and SAE reports are stored in DMIDS and are available for research to the appropriate institutions. Tasks of the BfArM Product group Non-active implants Reference 00268/07. The Field Safety Notice is only available in German. A product component may break, resulting in leakage and the risk of peritonitis. The BfArM also publishes data on shortages in the supply of medicinal products in cases assumed to be of especial interest to healthcare professionals. 17 The BfArM may allow in exceptional circumstances market access of medical devices, which have not undergone a regular conformity assessment procedure for CE marking, in Germany for a limited period of time, if this is in the interest of health protection. , Danvers, MA, USA, due to possible risk of shut down with no audible alarm. BfArM Recall Back. Brasseler , Download_VeroeffentlichtAm_EN 2009. During production the electrodes were assembled with wrong connector. Timespan: 2002 to present. Recall for test-kit PCT direct, BRAHMS, Download_VeroeffentlichtAm_EN 2009. The information on medicinal products provides the drug information system of the competent authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI (Paul-Ehrlich-Institut) and BVL (Federal Office of Consumer Protection and Food Safety). 28 PDF, 126KB, File does not meet accessibility standards All topics at a glance Reporting risks The database is part of the German database-supported medical devices information and database system. In general, the manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, and to advise on what action should be taken to protect the health or the safety of Recall actions: Medical device incident reporting & investigation scheme (IRIS) Database of Adverse Event Notifications (DAEN) Medical devices safety Medical Devices Safety Update: Brazil: Alertas: Recall actions: Technovigilance: Canada: Advisories, Warnings and Recalls - MedEffect Canada: Recalls and safety alerts: Health Product InfoWatch Field Corrective Actions include removals of medical devices from the market or any other corrective action on devices in use. 27 PDF, 1MB, File does not meet accessibility With the notification in the Art. Recall for the DePuy SIGMA HP FB TIBIAL TRAY IMPACTOR, Product group Optics / Precision engineering - endoscopes Reference 06984/13. The reference to the administrative finality is also not applicable. By clicking on ”find all field corrective actions”, you can set search parameters such as product group, format of communication and time period. Recall for the intraocular lens “SENSAR Foldable IOL with OptiEdge”, AMO, Recall for Compass PIP Hinge, Smith & Nephew , Download_VeroeffentlichtAm_EN 2009. 28 PDF, 42KB, File does not meet accessibility BfArM Recall Back. r. The BfArM does not receive any information on the reasoning for such a withdrawal and can therefore not publish any. 09. Medical device safety information published by the National Competent Authority Report (NCAR) Exchange Members. Recall of the silicon oil Siluron 1000 (syringes and vials, lot see annex) from Geuder AG. The action was initiated because of a packaging defect in manner of a cut in the double Tyvek pouch. conducts a recall of a defined number of Zyoptix® XP Microkeratome Motors. Recall of implantable Berlin Heart Incor LVAD due to possible risk of contacting problems at the point of connection between the cable and the pump. Recall of Acon Laboratories for the Quick-Chek Multi-Drug One Step Multi-Line 10 Drug Screen Test Device (lot number DOA5020322). An increased number of a broken female luer lock component has been observed. Lot recall of ATB Densitometer control Kit (reference 15512), bioMérieux SA, Download_VeroeffentlichtAm_EN 2016. Recall of Endurant / Endurant II 23 mm and 25 mm Bifurcated Stent Graft Systems, Medtronic 2017. Please update your bookmarks. 13 PDF, 43KB, File does not meet accessibility Product group Optics / Precision engineering Reference 01632/07. Recall / Upgrade for AQT90 FLEX Analyzer Software and Operator’s Manual, Product group Injections / Infusions / Transfusions / Dialysis Reference 03836/09. Customers were informed to discard the affected batches. -pharm. Current topics Common goal: Safe care with medical devices. 07. DePuy Synthes: recall of several Softlock forceps, Download_VeroeffentlichtAm_EN 2014. 311. Active substance: Vitamine B12 Information letter on Vitamin B12-ratiopharm N solution for injection: Recall due to visible particles. 2024. The manufacturer Synthes GmbH recalls all lots of the In-situ Bender/Cutter wide and narrow (model 530. prescribing physicians to select the most suitable treatment. Field Corrective Actions. An ACUITY cutting device is used during a pacemaker or defibrillator implant to remove a Boston Scientific guiding catheter after positioning a coronary venous lead. 02 PDF, 34KB, File does Product group Medical instruments for use in humans - vascular surgery Reference 01118/13. 06 PDF, 121KB, File does not This database contains Medical Device Recalls classified since November 1, 2002. According to § 67 a of the German Drug Act (Arzneimittelgesetz, AMG) the medicinal products The national texts are to be inserted into the “ Bescheidmaske ”, which is made available on the BfArM homepage. The action was initiated because of the possibility of a post-operative malfunction (stop distracting during treatment). To overview: Tasks of the BfArM; Product group Optics / Precision engineering Reference 01161/11. MEG 254030, 31, 32) because claimed limit of detection has shifted which may lead to false negative results. The failure mode identified is an overheating of transistors (FET) and subsequent shut down of the generator in ablation mode. This is due to the results of an ISO Batch / lot recall of i-Visc 1. The company Tyco Healthcare Ltd. The databases are part of the German database-supported medical devices information and database system. 11 PDF, 149KB, File does not meet accessibility standards All topics at a glance Reporting risks No parallel imported medicinal product may be imported or placed on the German market unless the company has received a corresponding licence by the national competent authority for human medicinal products – i. 12. By ordering a flat fee offer, you have access to the public databases. 001. BfArM - Federal Institute for Drugs and Medical Devices Recall of the Temporary Pervenous Pacing Leads – QSTIM from Biosense Webster , Download_VeroeffentlichtAm_EN 2006. Recall of several batches of the product Spiked Biopsy Forceps, Micro-Tech , Download_VeroeffentlichtAm_EN 2014. Type: Medical Devices, In vitro Diagnostics. 28 PDF, Recall of the Generation II Aorfix™ Stentgrafts from Lombard Medical , Download_VeroeffentlichtAm_EN 2007. BfArM - Federal Institute for Drugs and Medical Devices Fresenius Kabi has issued an information about a lot-recall of the following product: Ambix Intraport CP. The device may fall apart and the K-Wire got stuck inside. 08 PDF, 54KB, File does not meet accessibility Product group Non-active implants Reference 01736/08. Leonard Lang Medizintechnik GmbH has issued a Field Safety Notice concerning a recall of lot 01124-0776 of Skintact DF43N defibrillation electrodes, model 50086. Product group Non-active implants - special implants Reference 00737/14. 3200-1715 which were assembled by mistake without the white oval shield which covers the wire set’s rivet connection to the electrode pad. 03. Recall of the Morcellator Cutters 12 mm for Use with RotoCut G1 System (article numbers see annex) from Karl Storz GmbH & Co. Product group Non-active implants Reference 03890/09. This may be the case, if there is no alternative, i. 30 PDF, 248KB, File does not meet accessibility standards All topics at a glance Reporting risks Recall for Komet bone milling cutter H162SL, Gebr. Download DHPC / Information letter, Download_VeroeffentlichtAm_EN 2013. And it’s all in English too. Croma Pharma GmbH informs about a recall of all lots of the Quatrix® Aspheric Evolutive Yellow acrylic intraocular lens due to decoloration of the lens material. The manufacturer Gebrüder Martin GmbH informs about the recall of one lot of the Dilatator, De Bakey, because the solded tube of the dilatator may drop off at the end of the procedure. KG. Beginning January 3, 2017, the database may also include correction or removal actions initiated by a firm prior to Product group Injections / Infusions / Transfusions / Dialysis Reference 02983/11. While remodelling our website we adapted some contents to the new To overview: Public databases; Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. To overview: Operating the system; System requirements; Further tasks Product group Medical electronics / Electromedical devices Reference 04104/11. de. 521S and 530. Product group Surgical equipment/ Anaesthesia Reference 03283/08. Notifications of serious incidents and recalls as well as serious adverse events (SAE) continue to be made using the existing (online) forms available on the BfArM websites. More information as well as the report forms can be found on this The company Aesculap AG performs a recall of one manufacturing lot of Monosyn surgical suture, because its inner pouch may be damaged. Active substance: Vitamine B12 The reporting of suspected adverse drug reactions contributes to a better characterisation of a medicinal product's safety profile as well as to more reliable conclusions regarding its benefit-risk ratio. Read more. recall, warning), You can find device corrective actions, including recalls, on the German market from the Field Corrective Actions database on German To overview: Public databases; Database Information Medical Devices Notification; Database Information In Vitro Diagnostic Medical Devices Notifications; Database Information Medical Devices Addresses; Operating the system. Recall of gabmed for gabControl Strep A Test Cards due to false-positive results. Recall of Mast Diagnostics for the Mast ESßL Set (lot number 180127) because of false negative results. 04. The customers were informed about the problem and how to avoid it. The firm received reports about breakages of the cutter blades, whereby metal fibres could release and get into the patient. Potentially the the magnet (0,3x0,3cm) present at the distal end can separate from the device. Sterility of the affected devices cannot be guaranteed. The Product group Medical instruments for use in humans Reference 01279/09. Biomedica Medizinprodukte GmbH has issued an information about a product recall regarding the device BI-20052 Endothelin ELISA, Lot-Number 901C. Lastly, healthcare professionals should also The manufacturer Bode Chemie GmbH recalls several lot numbers of the desinfectant solutions Bacillol AF 500 ml and Bacillol plus 500 ml. Reference Number: mdprc 002 11 22 001: Date submitted: 11/15/2022: Manufacturer: Regen Lab SA: Device Type: A-CP Kits Family, RegenKit-BCT Family: BfArM update action: Please maintain the stop use and discard The address databases contain addresses of the persons reporting (MPADOE) and of the competent authorities (MPADC). Recall / Upgrade of Radiometer for AQT90 FLEX Analyzer Software and Operator’s Manual because the product exceeds specifications in two respects. Recall of certain lots of Alpha Durasul Inlays by Zimmer GmbH (see Advisory Notice) due to commingling of the products. Field Safety Corrective Actions (FSCA) Measures taken by BfArM. if the urgent medical need cannot be met The tasks of BfArM in the field of medical devices result in particular from the Medical Device Regulation (MDR) (EU) 2017/745, the Medical Device Law Implementation Act, the “Medizinprodukterecht-Durchführungsgesetz” (MPDG), the Medical Devices Act “Medizinproduktegesetz” (MPG) and the further implementing legal ordinances. To overview: Operating the system; System requirements; Further tasks Chad Therapeutics Inc. 05 PDF, 50KB, File does not meet accessibility standards All topics at a glance Reporting risks Product group Non-active implants Reference 04698/10. Type: Medical Devices. There’s a Product group Non-active implants Reference 01977/08. 29 PDF, 68KB, File does not meet accessibility standards All topics at a glance Covidien recalls certain lot numbers of the ProTack fixation device (Product Catalog number 174006), due to some devices firing only one helical tack and than becoming inoperable. According to the manufacturer Germany is not affected by this measure. , Database description for AMIce Terms of Substances; Tasks of the BfArM. 2009). 0309019249) because of the risk for falsely negative glucose results. Product group Non-active implants Reference 00950/07. Recall of all implant components of the ASR platform (DePuy ASR™ Articular Surface Replacement and ASR™ XL Acetabular System). , either the BfArM (Federal Institute for Drugs and Medical Devices) or the PEI (Paul-Ehrlich-Institut). Gerhard Mann chem. Recall of the Information letter on Vitamin B12-ratiopharm N solution for injection: Recall due to visible particles. MENTOR® Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) – Voluntary Product Recall (Removal) – October 11, 2021 . Recall for the Wire Tightener, Synthes , Download_VeroeffentlichtAm_EN 2013. BfArM - Federal Institute for Drugs and Medical Devices Product group Active implantable medical devices Reference 04007/09. Product group Injections / Infusions / Transfusions / Dialysis Reference 03836/09. Recall of the HemoCue Glucose 201 RT System from HemoCue , Download_VeroeffentlichtAm_EN 2007. To overview: Tasks of the BfArM; Clinical investigations and performance studies. g. 30 PDF, 863KB, Product group Active implantable medical devices Reference 04007/09. Given Imaging has issued a Field Safety Notice concerning the entire recall of PillCam Express Video Capsule Delivery Device, part number FGS-0367(3-Pak). Information on the topic "information system" can now be found at Medical Devices - Tasks - DMIDS - Public databases. The manufacturer Torax Medical Inc. Database Properties. Extensions and additional bookings of flat fees are also possible here. 13 PDF, 43KB, File does not meet accessibility Product group In-vitro diagnostics Reference 01999/09. Miele / Olympus has issued a field safety notice concerning recall of ECO process in the following ETD versions: ETD3 plus GA & ETD3 basic GA miniETD2 GA ETD2 / ETD2 plus GA miniETD. Synthes recalls the Wire Tightener, model number 03. No. Recall of the Persona EM Proximal Tube and Persona EM Distal Rod, Zimmer Biomet 2015. 522S). For each strength, a separate “ Bescheidmaske ” must be submitted in which the first pages (up to the signature) are completely filled in. European Database on Adverse Drug Reaction Reports; Risk Management Plans Tasks of the BfArM. Recall for Incor LVAD, Berlin Heart GmbH, Download_VeroeffentlichtAm_EN 2009. 29 PDF, Recall for the Airtraq optical laryngoscope, Prodol Meditec , Download_VeroeffentlichtAm_EN 2011. Database description for AMIce Batch Release; Tasks of the BfArM. ybvtl eju hijtn csot yev icnduh vpwvw bji sxbiuh erl