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.
Extra notes in the data
Reason
X-ray tube actuator shaft may fail allowing the mechanism to drop without warning.
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.
Extra notes in the data
Reason
Inspection of canadian importer infusystem canada indicated these unlicensed devices were being imported and sold.
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.
Extra notes in the data
Reason
Sterility seal on some of the wrist stabilization kit pouches may have seal integrity problems. in the event of rough handling gaps and/or voids may occur thereby compromising the product's sterility.
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.
Extra notes in the data
Reason
Integra lifesciences has identified through an investigation of complaints that some lot numbers of the integra led single bay battery charger (catalogue no. 90523) may prematurely fail and will not charge the integra led battery as intended. there have been no reports of an injury or other adverse patient consequences associated with the complaints. customers may have received an affected 90523 directly or had it provided with one of the following: led headlight systems (catalogue no. 90520us) or battery kits (catalogue no. 90530us).
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.
Extra notes in the data
Reason
Martel printers used with the i-stat system may become damaged due to the use of rechargeable battery packs that do not contain a fuse which have been purchased from suppliers other than abbott point of care. this notice reminds customers to only use the recommended battery available through abbott point of care.
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.
Extra notes in the data
Reason
In rare instances there is a potential for incomplete sample processing on the system if a specific wash carousel motion error occurs.
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.
Extra notes in the data
Reason
The abutment is oversized by 0.0028 causing it to not fully seat.
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.
Extra notes in the data
Reason
Storage condition printed on shipping container state 2-25 c and should state 2-8 c. the storage condition printed on the bottled product is correct (2-8 c).
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.
Extra notes in the data
Reason
Possibility of the burr head separating from the burr shaft during 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.
Extra notes in the data
Reason
The outer packaginf of dental impression material take 1 advanced lb wash super fast set has two contradicting labels: light-body fast set and super fast set. the product contains super fast set.
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.
Extra notes in the data
Reason
Labeling error. item k3 engine file g-pack labeled as k3 engine file vtvt pack and one enclised file was laser engraved as a .20 file but painted as a .25 file.
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.
Extra notes in the data
Reason
Part of the instructions for use for the bact/alert mb blood culture bottle was omitted with the last update. the affected section bact/alert mb culture bottle test procedure should include guidance on preparation of the mb/bact enrichment fluid vial.
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.
Extra notes in the data
Reason
Some devices were labelled as "does not contain dehp" even though the product may potentially contain small amounts of dehp. the company has not received complaints or reports of any patient injury associated with this mislabelling.
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.
Extra notes in the data
Reason
Potential for the sterile empty 30 ml pca vial and injector (list no.6021-001) for use with hospira pca pump to leak from the injector at the mal luer lock end. leaking vials can result in drug waste during filling or delay in therapy if it occurs during administration. if the reported leakage had occured during use on a patient the most likely effect is a necessity to replace the pca vial at an unplanned time or administer supplemental medication.
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.
Extra notes in the data
Reason
An investigation has confirmed that dd0004t v factor disc lot 1829520 has an incorrect barcode on the carton label. when scanned the barcode will incorrectly identify the product as dd0003t.
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.
Extra notes in the data
Reason
Stryker endoscopy has become aware that there is potential for a breach in the sterile packaging of the disposable scope warmers.
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.
Extra notes in the data
Reason
The assay values provided on the diskette do not match the assay values provided on the assay sheet.
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.
Extra notes in the data
Reason
Baxter corporation has issued a recall for the listed devices due to an increase in rupture complaints in product manufactured between november 2008 through january 2011. baxter has since implemented product and process improvements which have improved quality and reduced complaint rates for rupture. baxter wants to ensure that no affected product remains in the field.
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.
Extra notes in the data
Reason
There is a missing thread feature on both components of the device (the anterior and posterior adapters) that would make the unit unusable because it will not attach to the mayfield swivel adapter.
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.
Extra notes in the data
Reason
Defect in the motor castings has been identified which can cause the motor housing to break and could result in the total collapse of the bed and could cause patient injury.
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.
Extra notes in the data
Reason
Ortho clinical diagnostics (ortho) has identified that under specific circumstances the saline supply on the ortho vision analyzer may be insufficient to process tests without operator knowledge. if an operator opens the liquid access door for any reason the system software automatically resets assuming the saline container was refilled to the maximum volume of 4700 ml regardless of whether the operator refills the saline container or not. if an operator opens the liquid access door and does not refill the saline container to 4700 ml the system loses track of the actual onboard saline volume. therefore the system can no longer accurately determine low saline volume levels and alert the operator.
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.
Extra notes in the data
Reason
Poor or intermittent connections. a non functioning ccm could potentially cause the user to operate pumps using local pump controls.
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.
Extra notes in the data
Reason
A single digital encoder cable assembly during inspection had a loose wire further investigation revealed a deviation in the height of a wire crimp could lead to a loose wire.
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.
Extra notes in the data
Reason
A reaction cell that has already been used may remain on the carousel and be re-used leading to erroneous results.