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
Teleflex is recalling the product because the product labeling does not include the expiration date sterilization method or languages other than english. because the expiration date is not stated on the labeling there is a potential for expired product to be 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.
Notas adicionales en la data
Causa
Potential issue due to the possible improper application of a chronological label used in the hanging protocols - current prior or baseline labels which are used for review or interpretation from centricity pacs web diagnostic (dx) 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.
Notas adicionales en la data
Causa
It has come to the attention of devicor medical products inc. that a mst1009 probe for the mammotome revolve biopsy device in a stereotactic application may have been mislabeled. it is a 10 gauge device with a 9 cm needle. in lot number f11537107d1 a mst1009 was in a mst0815 package for a single unit. this single unit was identified by a customer and returned.
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
Sterilmed has initiated a medical device correction for all lots of listed sterilmed reprocessed depuy synthes stryker and smith & nephew external fixation systems. sterilmed has discovered the product label and ifu do not contain information regarding the safety and compatibility of the subject products in a magnetic resonance environment and such labeling is inconsistent with the oem labeling.
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
Sterile integrity of "bare boxes" (not shrink wrapped) shipped after september 1 2005 may have been compromised.
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
Label may state 'tempbond original' instead of tempbond ne.
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 determined there is the possibility that the device may not fully retract once it is deployed.
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
Cryolife was notified by the tissue bank that recovered this donor tissue of inconsistenceies in the medical/social history interview. specifically one or more questions that were used in determining donor eligibility were either not asked of the donor family or was not appropriately asked.
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 movement of the warmer head can put stress on the head harness connector. prolonged exposure to this stress can lead to electrical arcing at the connector which may lead to discolouration occasionally charring of the electrical connector or it can lead to a loss of electrical power to the heating element.
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
This recall has been initiated due to product below specified hardness. the tubes are too pliable and would be difficult to use for intubation. there is a possibility that the tube could fold over in the narrower areas of assembly. supplier of lts-d products noted in their process and informed king systems on jan 21 2011.
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
Zimmer is initiating a field action for sterile-packaged implants in two different package configurations due to packaging design verification test failures. specifically multiple test samples from each of the two configurations failed simulated distribution and shipping testing. the devices impacted are generally the heaviest outlier sizes within the respective product family.
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
Sigma 8000/8002 infusion pumps are not compatible with the recently redesigned hospira cair roller clamp. customers should not use the redesigned roller clamp with the sigma 8000/8002 infusion pumps.
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
Annual maintenance testing for the mckesson cardiology hemodynamic front-end parameter boxes: pb1000 & pb2000. mckesson cardiology hemo front-end boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes and to identify in a timely manner whether a parameter box is out of calibration.
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
The current chemistry information sheet (cis) pn 988626 af august 2010 for immage complement c4 states that customers may store samples frozen but does not specify a maximum frozen sample storage time. based on the internal testing conducted bec is updating the cis to include a maximum frozen storage time of no longer than 7 days.
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 internal evaluations omnyx became aware that variations in immunohistochemically (ihc) stained slide images may result from slides scanned with a limited number of idp vl120 scanners. further investigation determined that the installed scanner may have been manufactured with an out-of-specification led assembly. there have been no reported adverse events associated with 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
Draeger medical systems inc. has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16 which are used with the draeger infinity acute care system may permit liquid ingress inconsistent with their ipx4 rating which could potentially result in an incorrect measured value of invasive blood pressure.
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
Lot number on label printed on the wrong side of the platelet bag.
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
If the battery cap is not fully tightened down or if it is damagedthe pump may power down&brief chirp sound.Delivery of insulin is interrupted.If unnoticede.G. patient asleeprisk of potential harm to patient.
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 optical density of the kit positive control occasionally falling just below the minimun validity od required by the package insert(1.0 od for the high positive control) causing the run to be invalid.
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 lag screw insertion handle does not lock into the t-handle. discrepancy in size of insertion handle and t-handle which make fit slightly difficult.
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
Hologic has recently been notified by health canada regarding classification of the thinprep 2000 and thin prep 5000 processors. these products entered the canadian market as class i devices and it has been determined that these should be classified as class iii. this reclassification is the result of an administrative error and is completely unrelated to the safety and effectiveness of the thin prep processors. there are no issues or concerns with the safe and effective use of the thin prep 2000 or the thin prep 5000 processors and the integrity of all past current and future tests are not in question.
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
It is no longer a recommended option to implant a pace-sense lead while maintaining use of the fidelis high voltage conductors after a fidelis pace-sense conductor fracture has occurred.
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
Pointed end of a screw securing the occluder to the delivery wire could scrape off microscopic fragments of ptfe plastic lining of the sheath.
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
Change of level 3 error log messages to level 1 to prevent suspect assay results.