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
Hospira is issuing this safety notification to provide clarification wording for the technical service manuals of the plum a+/a+3 infusion pumps. the label revision is a re-wording meant to provide further context around need to inspect the fluid shield and the regulator closer to compliment the warnings that are currently part of the technical service manual.
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.
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Some potentially defective guider guide catheter product. this product is manufactured by boston scientific and the defect was caused by a manufacturing non-conformance that could lead to hub leaks in the resulting product.
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.
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As this is a sap recall this recall was not web posted.
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.
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Covidien is issuing a voluntary recall of all trellis 6 and trellis 8 peripheral infusion systems due to potential for a sterility breach of the outer packaging or pouch material. a breach of the outer pouch may comprimise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.
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.
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Degradation of the product when stored at 2-8 degrees c. no affect on negative results some increase of results for positives. bayer recommending storage at -20 degrees c or less.
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.
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Evolve hardware and software upgrade/update va47c.
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.
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Steris corporation has learned that cmax surigical tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. this could result in the table moving into an unexpected tilt position when the "level" button is depressed on the hand control keypad. the likelihood of this event occurring is remote as the cmax surgical table opertor manual states to always connect the ac power cord to an appropriate ac receptacle as often and as long as possible with the main power switch set to on.
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.
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The purpose of this notification is to inform nephrocare users of a possible software anomaly when using the "blue" lines standing order feature.
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.
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Autodelfia software could not recognize the pre-dilution factor given for result calculation if used in connection with additional loading functionality. this restriction applied only to autodelfia systems equipped with sample processor that are using ad software version v2.0 or v2.0 rev2.
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.
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Pump tubes that the yellowish/white tube may break off at the black plastic connectors. the breakage may occur during the installation of the tubes or after a short time 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.
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Causa
Stryker medical has identified a potential issue associated with secure ii and s3 med/surg beds built between april 2nd 2005 and july 26th 2011. the affected beds have the potential to experience damage to the foot end cover and/or power coil cable due to reduced clearance between the foot end cover and foot end lift header.
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 potential carton labeling discrepancy has been identified in association with 0.45% saline solution bottles. the lot number and expiration date indicated on the carefusion label applied to a shipping carton does not match the lot number and expiration date of the affixed biomerieux barcode label. the saline solution 0.45% is used in conjunction with the vitek 2 system for organism identification and/or antimicrobial susceptibility testing.
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.
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Causa
Change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia chemistry systems acetaminophen assay for the lots listed. this issue applies to the advia 1200 1800 and 2400 chemistry systems and advia chemistry xpt systems.
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
Abbott point of care inc. (apoc) has determined that i-stat g3+ cartridges from cartridge lot n13183 have the potential to exhibit incorrectly elevated pco2 and depressed ph results. abbott point of care has determined that some individual patient results generated with this cartridge lot have the potential to exhibit incorrectly elevated pco2 and depressed ph results. internal studies have demonstrated that pco2 results can be elevated by 10 to 25 mmhg ph results can be depressed by 0.10 to 0.15. all other g3+ cartridge lots are unaffected by 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.
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Causa
There are circumstances in which the 4ditc may be involved in a failure to correctly record treatment history information. the majority of the issues experienced fall into one of three general categories: 1)communication issues between the clinac sub-systems and the 4ditc 2)communication issues between 4ditc and the oncology information system (ois) 3) unplanned shut down of the 4ditc or the clinac during treatment.
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.
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Causa
This recall is being initiated by the manufacturer to reduce the chance of a blockage and improve the flow of water and chemical through the nozzle within the unit that would connect the 7th channel in a 7-channel scope to the innova unit. the size of this nozzle is currently 0.2 mm and it will be replaced by a 0.5 mm nozzle.
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
No adhesion between glue and peek of outer tube. gap in adhesive between 2 parts of ring block. missing adhesive between outer tube and ring block. pinhole in glue filled area between ring channel and ring block. micro cracks in glue after sterilization of ring probes.
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.
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Causa
Stryker medical has received complaints regarding scales and/or bed exit systems on gobed gobed+rosebed and gobed ii. the units cited were manufactured between march 1 2002 and june 302008. our investigation identified that the reported issues could be attributed to load cell malfunctions.
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.
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Causa
A firmware anomaly prevents the f&p sleepstylet from recording clinical data and may delay remote prescription changes if the device is continually powered for 20-50 days. this timeframe may vary depending on the number and length of therapy sessions.
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.
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Causa
Investigations have determined that this lot has an increased frequency of troponin i results >0.02 ng/ml for samples which are <0.02 ng/ml upon additional testing. any questions about previously reported results the recommendation would be to consult with your resident clinical expert or physician in the setting where the test was performed.
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.
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Causa
Hill-rom discovered that there were cases of malfunction being reported for the versacare series beds. users were indicating that after powering down and powering up the bed they noticed that all functions ceased to operate. therefore the product fails to meet its performance claim.
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.
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Causa
When astral ventilators are used with the internal battery as the sole power source it is important to note that failure of the internal battery can lead to cessation of therapy without the low battery or critically low battery alarm sounding even when the battery indicates that it is charged. this could put patients at risk to not getting therapy.