International device safety notices

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Continuing the International device safety notices list, 1000 records per page.

1. Recall of certain lots of the Inzii 12/15mm retrieval system, Applied Medical
2. Urgent field safety notice for dynamic seat shell system with undercarriage AKTIVLINE…
3. Urgent Safety Notice concerning Saliva Sample Collection Device Drug-Screen-Multi…
4. Safety Notice for the syngo.plaza, Siemens Healthcare
5. Safety Notice for Propaq LT / Propaq 802 Models 802LTAN, 802LT0N, 802LTRN, Welch Allyn
6. Urgent Field Safety Notice for Qitexio - 20ml Luer Lock Syringe by Medex SAS
7. Corrective action for AxSym Valproic Acid Reagent, Abbott
8. Recall for the Baxter Elastomeric Pumps Intermate LV 250 and SV 200, Baxter Healthcare
9. Urgent Field Safety Notice for VIDAS NT-proBNP2 by bioMérieux S. (Marcy- l'Etoile)
10. Corrective Action for Dimension Vista IRON Flex reagent cartridge, Siemens
11. Corrective action for Floseal Hemostatic Matrix (Floseal VH S/D), Baxter Healthcare
12. Urgent Field Safety Notice for DeepUnity Diagnost by DH Healthcare GmbH
13. Corrective Action for Enzygnost F1+2 (monoclonal), Siemens
14. Corrective action for recomWell Treponema IgM and ELISA Treponema Cutoff Control IgM (Lot…
15. Urgent field safety notice for syngo RT Oncologist, Siemens Healthcare GmbH
16. Safety Notice for the alfapump® System, Sequana Medical AG
17. Urgent Field Safety Notice for Trunnion handle/woodpecker by Stemcup Medical Products AG
18. Lot recall of sterile Teflon tube, catalogue number 18060073S, Stryker
19. Merck Millipore: Urgent Safety Notice for Anti-Lea Murine IgA Blood Grouping Reagent, cell…
20. Advisory Field Safety Notice for Male / Female Shifting Top Housing, Blatchford Products…
21. Urgent Safety Notice for the safety scalpel products in Bard Peripherally Inserted Central…
22. Lot Recall of the Facet Wedge Trial Implant w/rasp small cannulated, Synthes GmbH
23. URGENT FIELD SAFETY NOTICE for Zimmer Natural Nail CM Long, Zimmer Biomet
24. Urgent Safety Notice for the MiSeqDx™ System / MiSeqDx Illumina Worklist Manager Software…
25. Corrective Action for StreamLAB Automation Solutions, Siemens
26. Corrective action for specific da Vinci Si Single-Site gripping instruments, Intuitive…
27. Urgent field safety notice for Xprecia Stride Coagulation Analyzer, Siemens Healthcare…
28. Corrective Action for Alere Triage BNP, Alere Triage Profiler SOB Panel, Alere Triage…
29. Urgent Field Safety Notice for Voyager Evo Starrrahmenrollstuhl by Otto Bock Mobility…
30. Cobalt
31. Urgent Field Safety Notice for Esophageal/Rectal Temperature Probes by Philips Goldway…
32. Urgent Field Safety Notice for NOVOSYN by B. Braun Surgical S.A.
33. Urgent Field Safety Notice for PlastiSept eco by Alpro Dental-Produkte GmbH
34. Urgent Field Safety Notice for V40 Taper LFIT Anatomic Femoral Heads by Stryker…
35. URGENT FIELD SAFETY NOTICE for HeartMate II® System Controller, THORATEC CORPORATION
36. Safety Notice for the Discovery NM/CT 670 SPECT/CT and Discovery NM 630 SPECT Systems, GE…
37. Safety Notice for CentraLink™ Data Management System, Siemens Healthcare Diagnostics
38. Recall for the Neoss® Guide - Drill-Hub I and Neoss Guide Kit, Neoss Ltd.
39. Safety Notice for Centricity PACS, GE Healthcare
40. Safety Notice regarding MCS-Port Obturator / MCS5000, A. M. I. Agency for Medical…
41. Lot recall of DRI Salicylate Serum Tox Assay, Thermo Fisher Scientific / Microgenics GmbH
42. Lot recall of blood donor set 4-BB-SK-100-E, Fresenius Kabi Deutschland GmbH
43. Urgent Field Safety Notice for Lantis Commander oder Lantis System by Siemens AG…
44. Recall of several LENTIS IOL models (in glass vials), Oculentis GmbH
45. Batch recall of Hermann Gastrostomy Dressing Set, Fresenius Kabi AG
46. Urgent Safety Notice for the MammoDiagnost DR with advanced stereo, Philips
47. Urgent Field Safety Notice for Gas In-Line-Filter by Labotect Labor-Technik-Göttingen GmbH
48. Corrective action for the ADVIA Centaur Systems Calibrator E, Siemens Healthcare…
49. Urgent field safety notice for Prometra programmable pump (REF 91827), Flowonix Medical…
50. Follow-up Information for the Animas® 2020 and IR 1200 Insulin Pumps, Animas Corporation
51. Urgent Safety Notice for the MOBICATH™ Bi-Directional Guiding Sheath (small and large…
52. Urgent Safety Notice for the Azure Anterior Cervical Plate System, ORTHOFIX
53. Lot Recall of Cannulated Screw, SYNTHES
54. Urgent Field Safety Notice for Electronic Patient Gas System Flowmeter - APS1 by Terumo…
55. Corrective action for GENESIS II Saw Blades, Smith & Nephew, Inc.
56. Lot Recall for the product Elbow Hinge, ORTHOFIX
57. Waldemar Link GmbH & Co. KG: Recall for the Endo-Model® SL® - Connection Component, small
58. Safety Notice for Vivid E9 4D ultrasound system, GE Healthcare
59. Urgent Field Safety Notice for Reagenz zur Bestimmung von ALAT / GPT und CK-MB by LABOR +…
60. Urgent Field Safety Notice for TENEO by Sirona Dental Systems GmbH
61. Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme
62. Urgent Safety Notice for the ID cards "NaCl, Enzyme Test and Cold Agglutinins", DiaMed…
63. Safety Notice for bariatric bed Total Care, Hill-Rom
64. Recall of BD Sabouraud Agar with Gentamycin and Chloramphenicol, Becton Dickinson
65. Safety Notice for Seno Advantage versions 2.1 and 2.2, GE Healthcare
66. URGENT FIELD SAFETY NOTICE, Recall of guide wires labeled with a 10-year expiration date…
67. Urgent field safety notice for Afinion CRP, Alere Technologies AS
68. Recall for BRAHMS Osteocalcin KRYPTOR, ThermoFisher
69. Safety Notice for the Philips Allura Xper FD, Philips Healthcare
70. Information for Filter LCR5 T/B, Macopharma
71. Urgent Field Safety Notice for Anti-Lua (LU1) by Bio-Rad Medical Diagnostics GmbH
72. Corrective action for the Fully Automated Blood Coagulation Analyzer, Sysmex
73. Urgent Field Safety Notice for PrisMax, V2 ROW PrisMax V3 ROW by Baxter Healthcare S…
74. Expanded Corrective action for Spacelabs Healthcare Patient Monitor, Spacelabs Healthcare…
75. URGENT FIELD SAFETY NOTICE for MICroSTREP plus 1 (B1027-201), MICroSTREP plus 2…
76. Urgent Field Safety Notice for Morcellator 5-times-use-Model: moresolution V 2.0 by…
77. Corrective action for the seleXys TH+ and seleXys TPS shells, Mathys Ltd. Bettlach
78. Recall for Medex Angiographic-Puncture Needles, Smiths Medical
79. Safety Notice for the OR100 Neurosurgical OR table, IMRIS
80. Corrective action for the BFT II Analyzer, Siemens
81. Urgent Field Safety Notice for Alinity c Complement C3 Reagent, Alinity c Immunoglobulin A…
82. Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme
83. Lot Recall for the CerviFix Pedicle Clamp, SYNTHES
84. Urgent field safety notice for EnVeo R Delivery Catheter System, Medtronic
85. Urgent Field Safety Notice for Tests mit NAD(H) und/oder NADP(H) Reaktionsprinzip by…
86. Corrective action for the TRIGEN INTERTAN Lag Screw Length Gauge, Smith & Nephew
87. da4f1d84-f121-a395-9dd4-a7d6025451ef
88. Safety-relevant field measure for Artis zee Ceiling Systems, Siemens Healthcare
89. Urgent Field Safety Notice for CORAIL AMT Neck Segments by DePuy France SA
90. Safety Notice for the Arm-Shoulder-Blanket UniqueTemp°, Geratherm
91. Urgent Field Safety Notice for WASSENBURG endoscope washer-disinfector by Wassenburg…
92. Recall for the FiberOptix IAB Catheter, Arrow International Inc.
93. Corrective action for the Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON…
94. Urgent Safety Notice for the Patient Data Module (PDM), GE Healthcare
95. Corrective action for the CUSA® NXT/Selector® - Ultrasonic Surgical Aspirators Tubing…
96. Recall for the product Cutilyth sensitive Gel / Neutrosteralyth-Gel, AQUIS GmbH
97. Corrective action for the mass spectrometers, Waters
98. Urgent Field Safety Notice for Activa PC Neurostimulator, Activa S. Multi-program…
99. Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore…
100. Corrective action involving the P3 Medical Vented Tracheal Tube Guides (Bougies), P3…
101. Safety Corrective Action/Recall for PORT-A-CATH® Plastic Hub Needles, Smiths Medical
102. Recall for chromiD Strepto B, BioMerieux
103. Recall for Creatinine PAP FS, DiaSys
104. Urgent Field Safety Notice for OmniDiagnost Classic - OmniDiagnost-Eleva by Philips…
105. Safety Notice for upcoming safety inspection for Symbia E- or e.cam-system, Siemens…
106. Urgent Field Safety Notice for Grab rail Flex by Etac Supply Center AB
107. Urgent Field Safety Notice for GM85 by Samsung Electronics Co. Limited
108. Urgent Field Safety Notice for Vivexx Carotid Stent by Angiomed GmbH & Co. Medizintechnik…
109. Recall of MISAGO self-expanding stent system, Terumo Europe NV
110. Urgent field safety notice for BK Virus R-gene ® Real-time Detection an Quantification Kit…
111. Urgent Field Safety Notice for elisa 800 by Löwenstein Medical Innovation GmbH & Co. KG
112. Field Safety Notice for Infinity Acute Care System (IACS) in Neonatal Mode, Dräger Medical…
113. Lot recall of specific EndoWrist® Stapler 45 and 30 instruments for the da Vinci® Xi™…
114. Urgent Field Safety Notice for Sekusept, Incidin, Incidur by Ecolab Deutschland GmbH
115. Recall for the Perfusafe cannulas with Huberschliff, VYGON S.A.
116. Recall for the Sempermed Supreme surgical gloves, Semperit Technische Produkte…
117. Recall for specific lots of the Specialist 2 Intramedullary (SP 2 IM) Rod 400 mm…
118. Urgent Field Safety Notice for GenoType SugarTol VER 1.0 by Hain Lifescience GmbH
119. Urgent Field Safety Notice for FastPack IP Vitamin D Immunoassay by Qualigen Inc.
120. Urgent Safety Notice for the diagnostic ultrasound systems ARIETTA 60 & 70 series, Hitachi…
121. PRAC meeting highlights 26-29 September 2022
122. Siemens Atellica IM and ADVIA Centaur - negatiivsed kõrvalekalded tulemustes
123. Safety Notice for the IntelliSpace PACS system, Philips Healthcare
124. Urgent Field Safety Notice for Procedure trays: Bandscheiben Tray KH Vilsbiburg Spinale…
125. Corrective action for MagNA Pure 96 Instrument, Roche
126. Safety Notice for the Essenta DR Compact, Philips Medical Systems
127. Safety Notice for the product Compass 3.1, IBA Dosimetry GmbH
128. Urgent Field Safety Notice for DIPHOTERINE - PREVIN - HEXAFLUORINE by PREVOR
129. Urgent Field Safety Notice for schwarzer evo (EKG-Splitter ist Zubehör) by Schwarzer…
130. Urgent Field Safety Notice for IGG-2 by Roche Diagnostics GmbH
131. Important Product Information for HomeChoice and HomeChoice Pro Devices, Baxter
132. Urgent Safety Notice for the Monitor- Defibrillator DEFIGARD 5000, SCHILLER MEDICAL SAS
133. Urgent Field Safety Notice for MANI Trocar Kit by MANI, INC.
134. Corrective action for Elite XPL (Pulsed Light) Handpiece used with the MPX Laser System…
135. Urgent Field Safety Notice for Arterial Cannula by Edwards Lifesciences LLC
136. Safety Notice for Artis systems running software version VC21B, Siemens Healthcare
137. ProGrip Self gripping Polyester Mesh
138. Recall for the product Disposable Associate Cartridge + Disposable High Speed Vitrectomy…
139. Urgent Safety Notice for the device LINEA HDF ON-LINE, Medica S.p.A.
140. Urgent field safety notice for Etest ® Colistin CO256 WW (Ref. 537300 / 537308)…
141. Urgent Field Safety Notice for Dimension, Dimension Vista, Atellica CH, ADVIA Chemistry…
142. Urgent Safety Notice for the Allura Xper Systems, Philips Healthcare
143. Urgent Field Safety Notice for Diagnostic X-ray system GC80,GC85,GC70 by SAMSUNG…
144. Complementary information on the Recall of the Hyperion Extension Sleeves 25 mm and 30 mm…
145. Corrective Action for ADVIA Centaur CP - ADVIA Centaur Ferritin Assay, Siemens
146. Urgent Field Safety Notice for BCI Airway Adapters by ICU Medical Inc
147. Urgent Field Safety Notice for Palacos und Copal Knochenzemente by Heraeus Medical GmbH
148. Urgent Field Safety Notice for ARCHITECT Complement C3; ARCHITECT Immunoglobulin A…
149. Urgent Field Safety Notice for Spinous Process Clamp Tall and Short (Model 973471 by…
150. Urgent Field Safety Notice for Total IgE-HRP EIA by Dr. Fooke-Achterrath Laboratorien GmbH
151. Safety Notice concerning corrective actions of the Stryker Spring Arm (see below), Stryker…
152. Recall for the Cellacast Soft Semi-rigid Casting Tape, Lohmann & Rauscher
153. Urgent Field Safety Notice for RayCare 4A by RaySearch Laboratories AB
154. Urgent Field Safety Notice for recomLine ANA/ENA IgG by Mikrogen GmbH
155. Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH
156. Urgent Field Safety Notice for Cemento Mini Set for Cemento-MP by optimed Medizinische…
157. Safety Notice concerning EPIQ 7 Ultrasound systems with software version 1.0 and 1.0.1…
158. Updated Instructions for Use for the Navigated Solera Screwdrivers, Medtronic
159. Urgent field safety notice for the modification of the gantry base drive wheel assembly…
160. Urgent Field Safety Notice for Celsite T201 F by ICU Medical Inc
161. Recall for the Cup Insertion Instrument W/Thread M8X1 CVD, Aesculap AG
162. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
163. Safety Notice for the Patient Data Manager, Brainlab AG
164. Urgent Field Safety Notice for Remel Culti-Loops Candida albicans ATCC 10231 by Thermo…
165. Urgent Safety Notice for TheraSphere®-Y-90 Glass Microspheres, Biocompatibles UK Ltd…
166. Urgent Field Safety Notice for Cirrus-14 Wire Guide AQ Hydrophilic Coating by William Cook…
167. Access 2 Immunoassay Analyzer
168. Corrective action for Tests based on trinder reactions, Thermo Fisher Scientific Oy
169. Urgent field safety notice for LIFEPAK CR Plus AED and LIFEPAK EXPRESS AED, Physio Control…
170. Urgent Field Safety Notice for Randox Calibration Serum Level 3 by Randox Laboratories Ltd
171. Lot Recall for Osseotite® Tapered Certain® Implants, BIOMET 3i
172. Lot recall of autoX Extraction Kit, GFE Blut mbH
173. Urgent Safety Notice for BD Plastipack™ Syringes und BD™ Oral-Syringes included in the…
174. Urgent Safety Notice for the BD Plastipack™ Syringes and BD™ Oral-Syringes (included in…
175. Recall for the Tibial Resection Guide, Biomet
176. Recall of the IN.PACT® Amphirion Drug-Eluting Balloon (DEB), Medtronic
177. Urgent field safety notice for ProcedurePak kits and trays containing umbilical clamps…
178. Urgent Field Safety Notice for ACL TOP 3X0 CTS/ 5X0 CTS and refurb ACL TOP 970CL by…
179. Urgent Field Safety Notice for Perseus A500 by Drägerwerk AG & Co. KGaA
180. Recall for the SmartLife® Aseptic Housings, Stryker Instruments
181. Urgent Field Safety Notice for BD Plastipak Spritzen mit BD Luer-Lok Ansatz by Becton…
182. Urgent Field Safety Notice for Getinge CM320-series by Getinge Disinfection AB
183. Urgent Safety Notice for the VA-LCP Volar Distal Radius Plate 2.4, extraarticular, DePuy…
184. Urgent Safety Notices for the Lactate membrane units, when used with ABL700 and ABL800…
185. Corrective action for the EndoWrist® One™ Vessel Sealer, Intuitive Surgical, Inc.
186. Complete Recall of all Lenscare SH-System monthly contact lenses, 4CARE GmbH
187. Urgent Field Safety Notice for CareLink SmartSync Device Manager: 24970A by Medtronic Inc
188. Urgent Field Safety Notice for Astra, Azure, Percepta, Serena, Solara by Medtronic Inc
189. Urgent Safety Notice for Snowden-Pencer Tebbetts Fiber Optic Retractors, CareFusion
190. Urgent Field Safety Notice for Isla Cassis by Engelhard Arzneimittel GmbH & Co. KG
191. Recall for the Laryngeal Suction Tube with Soft Tip, Pennine Healthcare
192. Urgent field safety notice for Astral - Managing Degraded Battery Pack and Battery Update…
193. Urgent Field Safety Notice for SCHNEIDE-ELEKTRODE MONO 11,5CH 0° by Richard Wolf GmbH
194. Important Information about Animas® Vibe Insulin Pump, Animas Corporation
195. Safety Notice for the Extended Brilliance Workstation, Philips Healthcare
196. Recall of the 13F/15F Navigator™ HD Ureteral Access Sheath Set, Boston Scientific
197. Urgent Field Safety Notice for SQUALE by Orthopaedic & Spine Development
198. Urgent Field Safety Notice for PERI-GUARD by Synovis Life Technologies, Inc. (a subsidiary…
199. L25 Needle Guide Bracket
200. Randox Soluble Transferrin Receptors Cal & Control
201. SPOTCHEM II Glucose
202. Kii Optical Z-Thread Dual Packs
203. Corrective action for Artis systems used in conjunction with the Artis table, Siemens AG…
204. Urgent Field Safety Notice for Medline sterile kundenspezifische Sets (SPT) mit…
205. Safety Notice concerning corrective actions of cardioLife defibrillators series TEC-5521K…
206. Corrective action for the product ImmunoCAP ISAC sIgE 112, Phadia AB / Thermo Fisher…
207. Urgent Field Safety Notice for cobas c 501 module / cobas c 502 module by Hitachi…
208. Urgent Field Safety Notice for FDR Go by Shimadzu Corporation
209. Safety Notice for cobas c 701 and cobas c 702 modules, Roche Diagnostics GmbH
210. Urgent Safety Notice for PROCARE Monitors B20 or B40, Software Version VSP-A_1.10 (or…
211. Urgent Field Safety Notice for Thermo Scientific Oxoid Dryspot Staphytect Plus by Thermo…
212. Safety Notice for the YUNO extension device, Maquet Getinge Group
213. Guide Wire
214. Urgent Field Safety Notice for FRÄSER ABWINKELBAR Ø 4MM by Richard Wolf GmbH
215. Urgent Field Safety Notice for Smooth Muscle Actin (SMA), Biocare Medical
216. Recall of specific lots of the ExoSeal™Vascular Closure Device listed below, Cordis Corp.
217. Urgent Field Safety Notice for Brilliant Peel by Fluoron GmbH
218. MEDICAL DEVICE RECALL for IRMA TRUpoint® CC Cartridges, IRMA TRUpoint® BG Cartridges…
219. Urgent Field Safety Notice for CarboFlex by ConvaTec Limited Deeside
220. Urgent Field Safety Notice for Lokomat by Hocoma AG
221. Urgent Safety Notice for the Multigent Ammonia Ultra Reagent, Sentinel CH. Spa
222. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
223. Lot recall of Bardex 3 Way Male 30 cc / 50 cc Preshaped Ribbed Sac Lubricious Coated…
224. Urgent field safety notice for e.cam and Symbia E systems, Siemens Medical Solutions USA…
225. Urgent Field Safety Notice for FastPack IP Vitamin D-Immunoassay by Axon Lab AG
226. Recall for Alere Triage® Troponin I,Alere
227. Corrective action for the Oxoid Legionella BCYE Growth Supplement, Thermo Fisher…
228. Urgent Field Safety Notice for Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit by…
229. Urgent Field Safety Notice for KOPFBOHRER Ø 8,5MM by Richard Wolf GmbH
230. Safety Notice for Central Monitor CNS-6201 series, Nihon Kohden
231. Urgent Field Safety Notice for DxC 500 AU Clinical Chemistry Analyzer by Beckman Coulter…
232. Urgent Field Safety Notice for DI-60, Cell morphology analyser IVD, automated by…
233. Urgent Field Safety Notice for Giraffe Omnibed, Giraffe Incubator by Datex-Ohmeda, Inc
234. ADVIA Chemistry Drug Calibrator 1
235. Urgent Field Safety Notice for IPertussis Toxin gG Quantifizierungs-Set by Virotech…
236. Urgent Field Safety Notice for G6PDH by DiaSys Diagnostic Systems GmbH
237. Urgent Field Safety Notice for Euphora and Solarice Rapid Exchange Balloon Dilatation…
238. Urgent Field Safety Notice for Intro-Flex Percutaneous Sheath Introducers [Tray, 9F…
239. Urgent Field Safety Notice for Creatinine PAP FS by DiaSys Diagnostic Systems GmbH
240. Urgent Field Safety Notice for V-max Schiebehilfe by AAT Alber Antriebstechnik GmbH
241. Safety Notice for Artis zeego systems with SW revision VC14, VC20 and VC21, Siemens…
242. Recall Removal of the Vessix™ Generator System, Boston Scientific Corp.
243. Safety Notice for the SIEMENS Multix Swing X-Ray System, Siemens AG
244. Urgent Safety Notice for the Embru LINEA Hospital Beds, Embru-Werke AG
245. Urgent field safety notice for BCS / BCS XP - INNOVANCE ETP, Siemens Healthcare…
246. Safety Notice / Correction for the Patient Side Manipulators on the da Vinci S, Si and…
247. Safety Notice for the Allura Xper FD Systems, Philips Healthcare
248. Urgent field safety notice for KleenSpec® Corded Illumination System, Welch Allyn Limited
249. Weinmann Multifunction Electrodes - tagasikutsumine, ei salvesta kardiogrammi, ei anna…
250. Safety Notice for the NOMEX Multimeter, PTW (Physikalisch-Technische Werkstätten) Freiburg
251. Corrective action for the Brainlab iMRI Registration Matrix for GE, Brainlab AG
252. Urgent Field Safety Notice for VISIONAIRE LIGHTWEIGHT ALIGNMENT ROD by Smith & Nephew…
253. Safety Notice for the product MUELLER CUP, Biomet Deutschland GmbH
254. Urgent field safety notice for UniCel DxH Slidemaker Stainer Cellular Analysis System…
255. Urgent Field Safety Notice for Power Express, AU5800 Conn XL PW21 by Beckman Coulter, Inc.
256. Lot recall of Scorpio Patella Assembly Instrument, Stryker Orthopaedics
257. Urgent Field Safety Notice for ACTIV.A.C. Therapy System by KCI International, Inc.
258. Urgent field safey notice for Flocare Infinity enteral feeding pump, Nutricia Devices BV
259. Corrective action for Celsite® Access Ports, B. Braun Medical France
260. Urgent Field Safety Notice for Cera Plug by Lifetech Scientific Co. LTD
261. Lot Recall of suprapubic catheter kits, Urotech GmbH
262. Urgent Field Safety Notice for AssayTip / AssayCup by Roche Diagnostics GmbH
263. Urgent Field Safety Notice for IN.PACT ADMIRAL Paclitaxel-Eluting PTA Balloon Catheter by…
264. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
265. Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH
266. Urgent Safety Notice for the Swift Mobile shower chair, ETAC GmbH
267. Safety Notice for the RSP Monoblock Fixture, Encore Medical dba DJO Surgical LLC
268. Urgent Field Safety Notice for Persona Partial Knee Guide Size 8 by Zimmer Biomet, Inc…
269. Urgent Field Safety Notice for CombiDiagnost R90/ProxiDiagnost N90 by Philips Medical…
270. Recall for FreeStyle Lite® test strips, Abbott
271. Safety Notice for the AGC Tibial and AGC Femoral Impactor, Biomet UK Ltd.
272. Urgent Field Safety Notice for Copper, Clin Chem Control 1, Clin Chem Control 2 by…
273. Lot Recall of the Cadisc®-L Lumbar Disc Replacement Device, RANIER Technology Ltd.
274. Urgent field safety notice for Standard Offset Cup Impactor with POM-C Handle, Greatbatch…
275. Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare…
276. Urgent field safety notice for Mueller Hinton 2 agar + 5 % sheep blood (Ref. 43321 / 43329…
277. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
278. Urgent field safety notice for Perceval Sutureless Heart Valve, Sorin Group Italia S.r.l…
279. Urgent Safety Notice for the product "3D OPTICAL COHERENCE TOMOGRAPHY", Topcon
280. Corrective action for the Persona Distal Valgus Alignment Guide, Zimmer, Inc.
281. Electroneuromyostimulators with electrodes and accessories for signal transmission and…
282. Products for X-ray endovascular surgery with accessories: AXIUM detachable coils (AXIUM™…
283. Restylane SubQ Lido
284. 81ffff37-1fda-0d66-0ac9-329fbadd089e
285. Corrective action of BioMerieux for ZYM B, API Listeria, API NH
286. Urgent Field Safety Notice for Mueller Hinton E Agar (MHE) by bioMérieux S. (Marcy…
287. Urgent Field Safety Notice for Citrasate by MTN Neubrandenburg GmbH
288. Urgent Safety Notice for certain Karl Storz fiberscopes in STERRAD® Systems, Karl Storz
289. Urgent Safety Notice for the CARTOSOUND® Module of the CARTO® 3 EP Navigation System…
290. Lot recall of 1.5 mm Hydro Valvulotome, LeMaitre Vascular GmbH
291. Recall for Oxoid Antimicrobial Susceptibility Testing Disc F100, ThermoFisher
292. Recall of the E-vita THORACIC 3G Stent Graft System, Jotec GmbH
293. Urgent Field Safety Notice for Anaverse Glenoid, Liner by Zimmer Switzerland Manufacturing…
294. Safety Notice concerning the membrane changers and their inserts of V-Sign™ Sensors…
295. Urgent Field Safety Notice for PalaXtreme by Kulzer GmbH
296. Lot Recall for the ECLIPSE Cage Screw, Arthrex
297. Corrective action for the Prismaflex® control unit used together with the PrismaLung™ Kit…
298. Recall for the port cannula Ambix NONCOR®stick Safe, Fresenius Kabi Deutschland AG
299. Urgent Field Safety Notice for ADVIA klinisch-chemische Analysesysteme by Siemens…
300. Urgent Field Safety Notice for Syva EMIT 2000 Tacrolimus und Sirolimus by Siemens…
301. Urgent Field Safety Notice for Dimension, Dimension Vista by Siemens Healthcare…
302. Architect i1000 system
303. Corrective action for the MAS® CardioImmune XL Level 1 Control, Microgenics GmbH /Thermo…
304. Recall for the Bard® Dimension® Stone Basket, Bard Medical Division / C.R. Bard, Inc.
305. Urgent Field Safety Notice for Treadmill T2100 by GE Medical Systems Information…
306. Urgent field safety notice for IntelliVue Patient Monitors MX400 / MX430 / MX450 / MX500 /…
307. Urgent Field Safety Notice for Kalibrator TruCal U, Kontrollen TruLab N und TruLab P by…
308. Urgent field safety notice for CPX4 Medium Height Breast Tissue Expander 650 cc, Mentor
309. Urgent Field Safety Notice for BÜHLMANN GanglioCombi MAG ELISA by Bühlmann Laboratories AG
310. Recall for the AdVance™ XP Male Sling Systems, American Medical Systems (AMS)
311. Corrective action for the THERMOCOOL® SMARTTOUCH® Catheter Family, Biosense Webster
312. Urgent Field Safety Notice for Aequalis Ascend Flex Shoulder System by TORNIER SAS
313. Corrective action for the product NEFA FS, DiaSys Diagnostic Systems GmbH
314. Recall of Hip-med, Thuasne Deutschland GmbH
315. Urgent Field Safety Notice for Sterile Kundensets, die BD Komponenten enthalten by M.E.D…
316. Lot / batch recall of Dynesys pedicle Screw + Set Screw 6.0x35, Zimmer Biomet / Zimmer…
317. Urgent Field Safety Notice for IGA-2 (Tina-quant IgA Gen.2) by Roche Diagnostics GmbH
318. Corrective action for SD Bioline Tetanus, Standard Diagnostics
319. Urgent Field Safety Notice for Perfusor Space 12V-Anschlussleitung by B. Braun Melsungen…
320. Field Safety Notice using EN3-10 transducer and E-CUBE 9, ALPINION MEDICAL SYSTEMS Co…
321. Field Safety Notice with Navigation Software Spine & Trauma 3D 2.0, Brainlab Field Safety…
322. Corrective action for r ex-tem Reagent, TEM Innovations GmbH
323. Urgent Field Safety Notice for Flex-Pusher II by Occlutech AB International
324. Corrective action for the product LeoniPlus, Heinen + Löwenstein GmbH & Co. KG
325. Urgent Field Safety Notice for Universal Arm Support by TRUMPF Medizin Systeme GmbH + Co…
326. Corrective action for RealTime High Risk HPV and RealTime High Risk (HR) HPV m 2000 System…
327. Safety Notice STERRAD® 50, 100S, and 200 systems, ASP
328. Recall for the product OMNIFIX 20 ml LUER SOLO, B. Braun Melsungen AG
329. Lot Recall of the Original- Perfusor® Syringe 50 ml without cannula, B.Braun
330. Urgent field safety notice for PRIMEDIC AkuPak LITE, Metrax GmbH
331. Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent…
332. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
333. f166e78c-2930-1960-5122-584662be9765
334. Corrective action for ADVIA Chemistry Systems rer, Siemens
335. Urgent Field Safety Notice for Xpert BCR/ABL Ultra by Cepheid
336. Recall for the Dimension® HB1C Flex® reagent cartridge, Siemens Healthcare Diagnostics…
337. Corrective action for the product MectaLIF Oblique Handle, Medacta International SA
338. Recall of GlideScope GVL video laryngoscope, Verathon
339. Information for BacT/ALERT® 3D B.40.xx firmware, Biomérieux
340. Urgent Field Safety Notice for COR Disposable Kit, 8mm & 8mm w/Perpendicularity by DePuy…
341. Recall for the Trochanteric Fixation Nailing System (TFN), Synthes GmbH
342. Safety Notice for the REPLY, ESPRIT and FACIL pacemakers, Sorin Group Italia S.r.I.
343. Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott…
344. Urgent Field Safety Notice for FreeStyle Libre 2 by Abbott Diabetes Care Ltd. UK
345. Safety Notice for Dräger monitor arm AC3000, Dräger
346. Urgent field safety notice for N Latex ASL, Siemens Healthcare Diagnostics Products GmbH
347. Urgent Field Safety Notice for ENACT SEPTAL STAPLER 3 PACK by Smith and Nephew Inc
348. Urgent Field Safety Notice for Healing Abutment CC RP Ø3.6x5mm by Nobel Biocare AB
349. Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare…
350. Urgent Field Safety Notice for Holter System by Edan Instruments, Inc.
351. Urgent Field Safety Notice for Pneumococcus Factor 42a serum, 1 ml by SSI Diagnostica A/S
352. Recall of several sterilization indicators (STERRAD CycleSure 24 Biological Indicator) and…
353. Safety Notice for ADAC ARGUS and CIRRUS Gama Camera Systems, Philips Healtcare
354. Recall of Ethicon Vicryl™ Mesh Bag device, Johnson & Johnson International
355. Urgent Safety Notice RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc.
356. Urgent field safety notice for Viva CRT-Ds and Evera ICDs, Medtronic
357. Corrective action for the Wilkins Chalgren Broth + NAD, heipha Dr. Müller GmbH
358. Corrective action for the Vent Catheter, Edwards Lifesciences
359. Urgent Safety Notice for the Stryker Dekompressor® Percutaneous Discectomy Probes, Stryker
360. Safety Notice for the MiniMed 640G insulin pumps, Medtronic
361. Urgent Field Safety Notice for Hemoglobin A1c Calibrators by Abbott Laboratories
362. Safety Notice for the Arrow® Pressure Injectable Peripherally Inserted Central Catheter…
363. Recall of several batches of the product Spiked Biopsy Forceps, Micro-Tech
364. Recall for the Drill Templates and Saw Guides for LCP-Ulna-Osteotomyplates 2.7, Synthes…
365. Urgent Field Safety Notice for MRSASelect II by Bio-Rad Laboratories France
366. Urgent Field Safety Notice for LIFECODES HLA-DRB1 SSO Typing Kit by immucor GTI…
367. Urgent Field Safety Notice for Warming Solution Set 205, Warming Kit 102, Vitrification…
368. Urgent Field Safety Notice for LIFECODES HLA-DPA1/B1 SSO Typing Kit by immucor GTI…
369. Urgent Safety Notice for the Philips Expression Information Portal (IP5), Philips
370. dff1ac3a-080f-0ad1-989f-b6c5b994714a
371. Safety Notice for qube™ Compact Monitor, Spacelabs Healthcare
372. Alaris / Asena CC, GH Syringe Pump
373. Stratus CS CKMB DilPak
374. VOLISTA
375. Pulsavac® Plus Wound Debridement System and Pulsavac® Plus AC Wound Debridement System
376. Randox Serology I Positive Control - UUENDUS valenegatiivne testimine HBsAg markeri suhtes…
377. TITAN™ Total Modular Shoulder System (TSS) Humeral Stem Trials
378. Guedel Airway
379. Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
380. VENTAK PRIZM
381. Legacy P Implant
382. Arteriofix V
383. PRISMA M60 preset
384. d39cfb4f-714a-84fd-bfc2-ae8fe4ffe1d4
385. MoPyc Radial Head Prosthesis Impactor
386. QUADROX-iD Pediatric with BIOLINE Coating
387. Abbott MitraClip XTR Clip Delivery System - klambri avanemine liigse jõu avaldamisel…
388. Hydroxycarbamide-containing medicinal products – Potential interference with continuous…
389. Pennine Healthcare sondid, kateetrid - tagasikutsumine, tootmisdefekt
390. QLAB for Xcelera
391. Ligero
392. Mindray MR62 Defibrillation electrode - tagasikutsumine, ei salvesta kardiogrammi, ei anna…
393. NCL-L-vWF
394. Elecsys Anti-CCP - FSN Updated
395. Tome/Autotome RX Family
396. Trilogy Evo O2
397. PROWLER SELECT Infusion Catheters (pre-shaped)
398. Extraction Screw f/PFNA Blade
399. Arrow® Pressure Injectable PICC Set with Blue FlexTip® Catheter
400. Hem-o-lok ML
401. Servo-air, Servo-I, Servo-s, Servo-n, Servo-u
402. Abbott Alinity i, c Processing Module - kasutaja vigastamise oht, juhised õigeks…
403. c79c9dfb-2613-f79a-e86b-3f5ae2b43f71
404. ddc504c8-356a-0622-992c-18ea006aa45f
405. DeepUnity Diagnost
406. Tissu-Trans
407. EP-FIT PLUS/MPF Ceramic Insert Delta
408. Hintegra Tibial Alignement Rod
409. IgM-2
410. da Vinci® Standard, S™ and Si™ Surgical Systems Drapes
411. Oxoid Antimicrobial Susceptibility Testing Disc F200 (Nitrofurantoin)
412. Urgent Field Safety Notice for FreeStyle LibreLink App by Abbott Diabetes Care Ltd. UK
413. Safety Notice for the AU5800 Clinical Chemistry Analyser, Beckman Coulter
414. Urgent Field Safety Notice for Sternum guard by VYGON S.A.
415. Urgent Safety Notice for the SynchroMed® Implantable Infusion Pump, Medtronic
416. Urgent Field Safety Notice for Terumo OPS Valve by Terumo Medical Corp.
417. Corrective action for the CMF Mandible External Fixator System I and II, Synthes GmbH
418. Urgent Field Safety Notice for FG, CINCHLOCK FLEX KNOTLESS ANCHOR WITH INSERTER by Stryker…
419. Corrective action for the ADVIA Centaur®/ADVIA Centaur® XP Immunoassay systems, Siemens…
420. Recall for the product MicroVue Bb Plus EIA, Quidel
421. Urgent Field Safetv Notice for LIAISON® Cortisol, DiaSorin
422. Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive…
423. Freelite Human Lambda Free Kit for use on the Siemens BN ProSpec
424. Urgent Field Safety Notice for Prevision dist. curved Schaft by Aesculap AG
425. Urgent Field Safety Notice for Tests mit NAD(H) und/oder NADP(H) Reaktionsprinzip by…
426. Urgent Field Safety Notice for TactiCath S. by Abbott, Cardiovascular Division
427. Field Safety Notice for users of the MODULARIS Variastar, Siemens Healthcare GmbH
428. Balanced Body Studio Reformer - kõrgendatud vigastuste oht
429. Urgent Field Safety Notice for Elecsys Syphilis (200 test/kit) by Roche Diagnostics GmbH
430. CARDIOHELP-i
431. Urgent field safety notice for Y Connector 8-10mm, Vygon (UK) Ltd.
432. Safety Information for the Rocket® IPC Drainage Bottle, Rocket Medical
433. Urgent Field Safety Notice for AIRO Mobile CT System by Mobius Imaging, LLC
434. Urgent Field Safety Notice for Trilogy Evo O2, Trilogy EV300 by Respironics, Inc…
435. Recall for the Hercules™ 360 Universal Stabilizing Arm, Terumo Europe NV
436. Urgent Field Safety Notice for LIGACLIP Applier by Johnson & Johnson MEDICAL GmbH…
437. Corrective action for the Galt VTI® Valved Tearaway Introducer, Galt Medical Corp.
438. Urgent Field Safety Notice for HistoCore Spectra S. by Leica Biosystems Nussloch GmbH
439. Recall for the AMS 700 Accessory Kit - Lightning Bolt Keith Needles, American Medical…
440. Urgent Field Safety Notice for Upsylon Y Mesh Kit with Colpassist by Boston Scientific…
441. Urgent Field Safety Notice for EVE IN; EVE TR; EVE NEO by Fritz Stephan GmbH
442. Urgent Field Safety Notice for optimys Schaft lat. by Mathys AG Bettlach
443. Urgent field safety notice for RayStation 2.5 / 3.0 / 3.5 / 4.0 / 4.5 / 4.7 / 5.0 / 4.3…
444. Urgent Field Safety Notice for Perceval Sutureless Aortic Valve by LivaNova Canada Corp.
445. Advia Centaur XP
446. Urgent Safety Information for the product Incor® Control Unit, Berlin Heart GmbH
447. Urgent Field Safety Notice for Venodrop by F.M. S.p.A.
448. Urgent Field Safety Notice for Evita V800, Evita V600, Babylog VN800, Babylog VN600 by…
449. Urgent Safety Notice for the Flexible Bronchoscopes and Intubation Fiberscopes, Karl Storz…
450. Urgent field safety notice for Dimension Vista System Calcium Flex reagent cartridge…
451. Urgent Field Safety Notice for Cardiosave Hybrid Intra-Aortic Balloon Pump by Datascope…
452. Urgent Safety Notice for Etest® Ceftaroline blisters products, bioMérieux SA
453. Corrective action for the Philips IntelliVue Patient Monitors and Philips Avalon Fetal…
454. Urgent Field Safety Notice for Sinapi Thoraxdrainage-System by Primed Halberstadt…
455. Recall of Sleep Safe Sets, Fresenius Medical Care GmbH
456. Recall for the Kirschner wire, Zimmer GmbH
457. Urgent Field Safety Notice for EKOS Control System 4.0 by EKOS Corporation
458. Urgent Field Safety Notice for ADVIA® Chemistry Systems Hemoglobin A1c_3, Siemens…
459. Urgent field safety notice for Monaco, Elekta / IMPAC Medical Systems Inc.
460. Urgent Field Safety Notice for Dimension Vista® Systems Magnesium Flex® reagent cartridge…
461. Batch recall of ORG 908MX Anti Mumps Virus IgM, ORGENTEC Diagnostika GmbH
462. Urgent Field Safety Notice for AXIOM Artis/Artis zee by Siemens Healthcare GmbH Advanced…
463. Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.
464. URGENT PRODUCT RECALL for PenBlade Safety Scalpels, ZIEN Medical Technologies
465. Recall of HVAD pumps, HeartWare
466. Urgent Field Safety Notice for VICI VENOUS STENT and VICI RDS Stent Systems by VENITI…
467. Recall for HT Connect Peripheral Guide Wires, Abbott Vascular
468. Urgent Field Safety Notice for SOLOPATH® Expandable, SOLOPATH® Re-collapsible by Terumo…
469. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
470. Urgent Field Safety Notice for FluoroSoftware IVD used with FluoroCyclers 12 & 96 by Hain…
471. Corrective Action for ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP, Siemens
472. Batch Recall of the Toptex lite Laparotomy swabs, Lohmann & Rauscher
473. Extended recall for Topex lite RK Labaratomy Swab, Lohmann & Rauscher
474. Corrective action from for Estrogen Receptor Ab-11, Thermo Fisher
475. Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed
476. Urgent Field Safety Notice for Liquid Cardiac Control by Randox Laboratories Ltd
477. Safety Notice for the Artist System, Siemens Healthcare
478. STA-R Max
479. Corrective action for the products Discovery MR750, Optima MR450w and Discovery MR750w, GE…
480. Urgent Field Safety Notice for Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit by…
481. Urgent Field Safety Notice for VITROS Performance Verifiers I & II by QuidelOrtho (Ortho…
482. Urgent Field Safety Notice for MINICAP IMMUNOTYPING, CAPILLARYS IMMUNOTYPING, CAPI 3 by…
483. Urgent field safety notice for Simplexa Flu A/B & RSV Direct assay / Simplexa HSV 1 & 2…
484. Urgent field safety notice for Simplexa Flu A/B & RSV Direct assay / Simplexa HSV 1 & 2…
485. Urgent Field Safety Notice for MicroVue C4d Fragment EIA by Quidel Corporation Athens
486. Urgent field safety notice for West Nile Virus IgG DxSelect kit (EL0300G), Focus…
487. Urgent field safety notice for West Nile Virus IgM DxSelect, Focus Diagnostics
488. Urgent Field Safety Notice for BIOSAFE MD-smart by Cryotherm GmbH & Co. KG
489. Urgent Safety Notice for the DAR™ Breathing System, Mapleson B and C configurations…
490. Lot recall of sanabelle I800 PEG/SPK bandage set or Freka bandage set SPK/PEG, medi1one…
491. Corrective action for BD BACTEC™ FX - Top Unit, Becton Dickinson
492. Urgent Field Safety Notice for Bedside to Patient Unit Cable (PURU3) by Natus Medical…
493. Urgent Field Safety Notice for LED Surgical Light by NANJING MINDRAY BIO-MEDICAL…
494. Corrective Action concerning Oxoid Columbia Agar with Sheep Blood PLUS PB 5039 A (Lot- No…
495. Urgent Field Safety Notice for Nimbus 4 & Nimbus Professional by ArjoHuntleigh AB Malmö
496. Safety Notice for the Instrument Star Unit ML, Brainlab
497. Recall of one batch of the Reflection Polyethylene Acetabular Liners, Smith & Nephew
498. Urgent Field Safety Notice for TiMAX 6.5mm/8.0mm Large Cannulated Screw System by Biomet…
499. Urgent Field Safety Notice for cobas p 612 pre-analytical system, Roche
500. Urgent field safety notice for Rotaio Cervical Disc Prosthesis, Signus Medizintechnik GmbH
501. Urgent Field Safety Notice for SPIF by BALT Extrusion
502. Urgent Safety Notice for the Portex® Arterial Blood Sampling Line Draw Syringes, Smiths…
503. Lot recall of Triglyceride concentrated (TRIG_c) reagent, Siemens Healthcare Diagnostics…
504. Safety Notice for Artis biplane system, Siemens Healthcare
505. Urgent field safety notice for VITROS Chemistry Products Slide Assays, Ortho Clinical…
506. Urgent Field Safety Notice for Trigo Sport by HASE-Spezialräder
507. Recall for “Laparascopic Instruments” due to a reprocessing issue, Rudolf Medical
508. Ortho BioVue System Cassettes for ABO, Rh, Kell grouping/typing
509. Corrective action for Liaison® Control Biotrin Parvovirus B19 IgM, Diasorin
510. Urgent Field Safety Notice for Arcroyal Procedure packs containing B.Braun Vasofix Safety…
511. Safety Information concerning the HP M.B.T. Keel Punch Knee Instruments, DePuy Synthes
512. Folgeinformation VIDAS®3, bioMérieux
513. Corrective Action for all Access/Access 2 Immunoassay-Systems, SYNCHRON LXi 725…
514. Urgent Field Safety Notice for Single Chamber Temporary Pacemaker by Medtronic Inc
515. Urgent Field Safety Notice for PolarSheath Schleuse by Boston Scientific Corporation…
516. Urgent Field Safety Notice for ADVIA®Chemistry Systems, Alkaline Phosphatase, Siemens…
517. Corrective action for the OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800…
518. Urgent Field Safety Notice for FiLaC Fistula Kit, LHP® Procedure Kit, HeLP Procedure Kit…
519. Safety Notice concerning the implantable infusion pump Lenus pro, Tricumed Medizintechnik…
520. Urgent Field Safety Notice for IRON 2 by Roche Diagnostics GmbH
521. Recall for the ADEPT® Hip Resurfacing System, MatOrtho Ltd.
522. Bush DL/SL Ureteral Illuminating Catheter Set
523. Safety Notice for the Calcitonin Elisa Kits, Quidel Corp./MDSS GmbH