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
Phix lot 1b3832 was given the expiration date of 09 may 03 when the correct expiration date should be 09 may 02.
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
Incident en obstetrique ou le connecteur du catheter a succion a ete detache du tube lorsque retire rapidement.
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 potential exists for the ball type thrust bearing to fracture from over-tightening of the door closing device causing an explsive release of steam from the autoclave.
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
Inline post-processed image locations are not correctly annotated under some conditions. also reference images displayed in functool fibertrak do not match with the orientation annotations under some conditions.
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
When non-keyboard mode was used to enter unacceptable result in bllod product testing & tab key was not selected to move cursor to next field unacceptable product result processing did not 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.
Notas adicionales en la data
Causa
An idiosyncrasy has been identified in the operation of the icon and e.Spft workstations which may result in incorrect orientation of acquired patient data in "spect" mode.
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
Us endoscopy has identified that the expiration date is incorrect on the outer packing label for roth net polyp retrieval (00711151 lot 1613898). the expiration date printed is earlier than the actual expiration date. the performance of the product is not impacted. it is important to note that all individually labeled roth net devices contained within the outer shipping package reference the correct expiration date.
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
Complaint activities have been observed in the field for sleeve non-recovery sleeve leakage and sleeve fall off (pop-off). the potential hazard is blood leakage from the back end of the device (due to sleeve malfunction).
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
Ortho clinical diagnostics (ortho) identified the potential for intermittent imprecision in results generated using affected lots of vitros li slides. when present the potential imprecision does not affect random slides but rather sequential slides within or across slide cartridges caused by a short-duration imperfection during manufacturing.
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
Product contained incorrect barcodes where the labels began with "43 02" rather than the required "43 01". these batches were placed on quality notification and dispositioned for rework to over-label the barcode area with the correct symbology. the over-label was manually applied to each tube. one customer complaint was received where the over-label had partially peeled off of the tube the incorrect barcode underneath was scanned into the mgit instrument and the epicenter connected to the customer's laboratory system incurred an error. the customer also noted that they found additional tubes in their shipment that had multiple labels or no over-label. the label prefix specifically the 3rd and 4th digits that indicate the media type gives the instrument information for what algorithm to apply for growth detection. growth detection testing will be performed by the mgit instrument every 60 minutes as usual on tubes containing incorrect barcode prefixes but will not flag as positive when growth is visible because media type "43 02" is not defined. a barcode overlabel peeling off exposing an incorrect barcode causes mgit false negative results by not flagging positive tubes. susceptibility tests are not affected since susceptibility testing is conducted in a carrier where instrument instruction is provided by the carrier.
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 reflex hybrid screw extractor inner shaft was reported to fail at the threaded tip and fracture in the head of the screw. there had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. there had also benn reports of damage to the screw and/or the plate while attempting to remove the screw.
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
A trend in complaints of difficulty in passing a suction catheter or locking the et tube holder in place was observed. smith medical's investigation determined that the fastener component and cylinder component on the et tube holder could cause compression of the tracheal tube when assembled together. the investigation determined that in some cases the fastener and cylinder could compress the tube enough to affect the tracheal tube inner diameter. customer feedback suggested that difficulty passing suction catheter usually occurred when a size 6fr suction catheter (or larger) was used.
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
Synchron systems high sensitivity c-reactive protein (crph) reagent lot m505223g may genereate recoverites that are falsely increased by up to 27%. will affect both controls and patients' samples.
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 potential for the fowlers (backrests) to drift down to the flat position on the beds. the cause of the drifting fowler is the fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the fowler clutch assembly.
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
Marketlab had determined that the face shield with drape required a recall since the hook-and-loop fasteners application was on the incorrect side of the drape. as a result of the hook-and-loop fasteners being on the incorrect side of the drape the drape will not gather and stay gathered for the under chin hugging effect.
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
Notification regarding corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation (scs) therapy. current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios.
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
Boxes of 510-101 lot 53226 and 500-101 lot 53240 were packaged at the same time during final packaging. final packaging consists of placing sealed sterile pouched tubes in boxes and labeling the boxes. some of the final packed boxes had a mixture of these two tubes. all pouches were packaged and labeled correctly.
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
Manufacturer has detwermined that these lots do not demonstrate acceptable performance and patient samples may exhibit falsely high factor viii results could lead to misdiagnosis.
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
Blank rate high (sh) instrument flag may be generated when less than 30 tests left in the co2e cartridge and recalibration attempts may fail or may not be maintained.
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
Ventilator may on rare occasion reset spontaneously during normal operation without an accompanying alarm.
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 have been a few cases where a newly installed medical air compressor experienced a malfunction no longer providing sufficient supply pressure to the connected medical ventilator.