Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Chirstom safety note regarding the withdrawal and use of certain series of Nabatoff varicose veins
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Security memo of ARKONA Trade and Science Grzegorz Kalbarczyk Sp. J. concerning the withdrawal from use and use of some series of nasal spray SOLIK complex
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Security note from Solinea Sp. z oo Sp. K. regarding the withdrawal from use and use of the Ectodose X721B inhalation solution manufactured by the Bitop AG company
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Security memo of ARKONA Trade and Science Grzegorz Kalbarczyk Sp. J. concerning the withdrawal from the market and use of the GLOSAL throat spray series 2013-03-05
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Safety note of the SUMI company Zakład Tworzyw Sztucznych K. Rek A. Krzanowski SJ concerning withdrawal from the market and use of tracheostomy tubes without a cuff, no. category beginning with figures 33 and from 10.01.01 to 06.16.06
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Security note from Solinea Sp. z oo Sp. k. concerning the withdrawal of the Argenton optic eyelid spray with the A02 series
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Difficulty has been experienced in removing the stent delivery system in one instance the stent became deformed during the attempt to removal.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Memorandum of safety of the Polpharma Pharmaceutical Plant concerning the withdrawal from the market of the medical device Nebu Muco 7% NaCI inhalation solution, series 10816
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notes supplémentaires dans les données
Action
Announcement of the WSM GALMED company regarding drains for REDON wounds (07.05.2008)
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The wiring harness could short circuit creating an overheating condition that can damage the wires and create a potential for a fire.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
This problem affects revision c and d of the software. in rare circumstances the settings for paper scale type and recorder speed may revert back to the factory default settings which are: us paper style and 3 cm/min paper speed. this behaviour would have the most impact in europe and asia/pacific where other settings are preferred. if this change remains undectected by the user it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. the problem occurs when the power-up/boot sequence of the fetal monitor is interrupted e.G. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Medtronic xomed is expanding the original product safety advisory for medtronic external nasal splints and thermasplints (incident 62165) to advise consignees to immediately discontinue using and dispose of the skin-prep protective wipes packed together with the affected medtronic nasal splint kits.The smith & nephew skin-prep protective wipes are contract manufactured by the triad group in the same facility where the alcohol wipes subject to the original field action are manufactured.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Portion of recalled lot number contains plates with product information incorrectly stamped on the plate as bbl columbia ana sb.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Through testing it was determined that this product may have an elevated incidence of false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. as with all diagnostic tests all results must be interpreted together with other clinical information available to the physician. the root cause is still under investigation.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Potential for the presence of a plastic srand at the top of the test strip vial that could prevent a proper seal between the vial and the lid potentially leading to a wrong result.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
6 complaints have been received where there have been leaks at the female end of the texium device when connected to the male spin luer at the end of a primary set. no complaints have occurred in canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Exchanging the laser warning label (device not yet installed or in use).
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. if a table is found to have these incorrectly manufactured parts it is possible for the table's elevation column slide cap to become detached from the elevation column. this could result in the loss of control of the table top and injury to the patient or staff.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Cardinal health has determined the specimen pitchers (fg65-4357a the specimen pitcher graduated 1200 cc) contained in these presource kits may be brittle due to design changes. as a result of stacking the pitchers inside each other breakage of the small internal ribs of the pitcher may occur.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Notes supplémentaires dans les données
Cause
Medtronic is mailing a safety notification to physicians associated with the synchromed infusion pump. this notification provides important information on medtronic neuromodulation's continuing efforts to investigate and communicate the impact of unapproved drugs on the performance of the synchromed infusion pump system. it includes information on motor gear corrosion which has been identified as the primary contributor to pump motor stall in the synchromed ii and synchromed el pumps. this communication is intended to reinforce with healthcare professionals the importance of following the labeling with respect to the use of indicated drugs. all active implanting or managing physicians associated with the synchromed drug infusion pump are in scope for this communication.