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.
Notas adicionales en la data
Causa
During stability testing an out of specification ph was found prior to the 12 month expiry date in the various product code glass bottles.
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.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of the potential for the rotating iv pole to fall due to excessive tap drill depth resulting in a thin wall section of the block bracket assembly which is the bracket that attaches the pole to the bed. a fall could result in an injury to a bystander holding the patient or to the operator. there have been no injuries as a result of this issue.
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.
Notas adicionales en la data
Causa
Mislabeling issue. sawblades labeled as profix (old style) stryker rather than profix hall 3/4 fanned.
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.
Notas adicionales en la data
Causa
There is a potential for the gas sampling line to be occluded/blocked. this affects individual lines and those which are components within kits.
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.
Notas adicionales en la data
Causa
1. during a biopsy examination the system may freeze leading to the footswitch not releasing the compression. 2. there is potential fr the bucky table brake (tomo clutch) to be damaged when it is incorrectly adjusted.
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.
Notas adicionales en la data
Causa
Stryker has become aware that periodic testing normally completed during the manufacturing process was not conducted for products manufactured between march 28 2014 and may 2 2014. changes to the quality of the weld during this period may not have been detected and may be less effective than intended.
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.
Notas adicionales en la data
Causa
Decrochement de la traverse. la cause initiale de cette defaillance est la contamination de la matiere premiere de l'arbre pivot qui retient la traverse.
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.
Notas adicionales en la data
Causa
2 lots of heparin contaminated with oversulfated chondroitin sulfate were used to manufacture some lots of carmeda-coated cardiopulmonary bypass productsincluding affinity nt hollow fiber oxygenator with cbas.
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.
Notas adicionales en la data
Causa
The constituent inhibin a was removed from mas omni-immune and mas omni-immune pro controls however the package insert was not updated to reflect removal. the affected lots ahould not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.
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.
Notas adicionales en la data
Causa
During the weighing procedure the scale is programmed to give only 6 seconds to place the baby on the mattress if it takes more than 6 seconds to place the baby on the mattress the scale will display an inaccurate weight.
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.
Notas adicionales en la data
Causa
The previous results retrieved from the specimen management database which may be used by rules may not be the most recent previous version.
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.
Notas adicionales en la data
Causa
Pump may stop without an audible tone as a result of a quickly clearing internal pump alert/alarm or overpressure alert/alarm condition.
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.
Notas adicionales en la data
Causa
During packaging of some non sterile non patient use demonstration fiber-optic iabc the ferrule cap was not removed.If the connector is inserted into patient use maquet cs300cardiosave intra-aortic balloon pump or iabp upgraded with fiber optic module cap may become dislodged and remain in receptacle of pump.
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.
Notas adicionales en la data
Causa
Implant direct sybron manufacturing llc is recalling 3 lots of the dgde directguide drill extender (dgde) and 22 lots of associated products that contain dgde as an accessory. through internal regulatory affairs evaluation (hhe) process company found a possible safety issue with the retention of the drill when the dgde is in use. this discrepancy may lead to the possibility of the dgde dropping the drill. the company's current data indicates the possibility of this occurring is unlikely (0.69%).
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.
Notas adicionales en la data
Causa
Medtronic powered surgical solutions testing of the sagittal saw rocker arm seal identified a potential for leakage of fluid into the motor during use. there have been no reports from the field of leakage into or out of the sagittal saw. in assessing the risk of this potential failure mode it was determined that the gravity sterilization cycle included in the ipc user manual may not be adequate to ensure sterility of the saws if fluid ingress occurs beyond the rocker housing seal.
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.
Notas adicionales en la data
Causa
On dec 16 2002 confirmed that the distal end of the megatip cautery tip broke off during a laparoscopic procedure and was not retrieved by the surgeon. investigation revealed stress cracks in the tip.
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.
Notas adicionales en la data
Causa
Virtual wedge importation using rtpx will appear in rtp column not in varis column. affects other wedge parameters. no warning given.
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.
Notas adicionales en la data
Causa
Ethicon is expanding the april 2014 global commercial suspension and initiating a worldwide voluntary market withdrawal of all ethicon morcellation devices including generators and disposables that currently remain in the market. the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.
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.
Notas adicionales en la data
Causa
There is a potential that the fluorescent platelet (plt-f) count and immature platelet fraction (ipf %) results performed using fluorocell plt lots a5053 or a5054 may exhibit lower than expected plt-f and ipf values. this reagent is used only on the sysmex xn-series hematology analyzers for the plt-f and ipf% parameters.
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.
Notas adicionales en la data
Causa
A particular component may not have been fitted correctly during the installation of some mavig portegra 2 systems (a ceiling suspension system). the component in question is not actively involved in the operation of the mavig portegra 2 system and its absense does not have an adverse effect on system function. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose leading to an adverse effect on the function and possibly becoming detached from the system.
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.
Notas adicionales en la data
Causa
Potential bacterial contamination of certain lots of uni-solve adhesive remover wipes manufactured by the triad group for smith & nephew and co-packaged in the medtronic site adhesive sample kit.
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.
Notas adicionales en la data
Causa
Defective integrated circuit on main circuit board.Cdi system 500 could potentially not work after power loss.
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.
Notas adicionales en la data
Causa
Echocardiography volume measurements that were performed within crs were not reflected correctly in associated results management (rm) reports. this occurred when echocardiography volume measurement data was not saved correctly within the crs persistence data and in the rm database. the issue was caused when point-trace mode was enabled in crs a feature that was introduced in crs 2.12.05. a software upgrade to crs 2.14.03.Su2 will be made.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Potential for the distal (occlusion) pressure sensor pin to break on plum a+ infusers.