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 manufacturing quality issue with the t-piece circuits for the panda and giraffe resuscitation system integrated into the infant radiant warmers. this issue occurs when then t-piece resuscitationcircuit is not able to achieve maximum pip (peak inspiratory pressure) of 45+/-5 cmh2o as measured by the built-in airway pressure manometer during the pre-use checkout procedure.
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
Fresh gas leak developed between the vaporizer and the manifold caused by the rear cover of the vaporizer being distorted and could become weakened during label removal portion of the service process.
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
Under certain conditions the adu may deliver air instead of n2o as the air/n2o selector becomes stuck in the air position.
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
O-ring on rh12 rotor assembly (pn:x00-002227-001) rev b and rev ba used on the statspin centrifuges may dislodge during operation and lead to a possible sample 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.
Extra notes in the data
Reason
There is a possibility that power suppy unit (psu) may break or the system will not start up.
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
Elevated recticulocyte results observed as demonstrated by a left shift or double peak of the histogram. in some cases the results may exceed normal range on normal specimens without a data flag observed.
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
This voluntary recall is being initiated as a result of com15aints of false positive het mutations (9 complaints) and leaking cards (2 complaints) reported to hologic. internal investigations have determined that the false positives and leakage were most likely caused by manufacturing defect at a key component supplier.
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
1)absence of black indicator markings on the metal tip and 2)fiber degradation (degradation of fiber detachment of metal cap and fiber lasing straight) during use for devices manufactured after feb.1/06.
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 operation manuals containing reprocessing instructions have been updated to reflect newly validated manual cleaning and high-level disinfection procedures. given publicized reports of multi-drug resistant bacteria on certain duodenoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures and in an abundance of caution fujifilm has been working with the fda to validate revised reprocessing procedures that have been provided in the operation manuals. healthcare providers are being instructed to follow the exact instructions for reprocessing provided in the revised operation manuals in order to minimize the risk of disease transmission.
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 channel configuration in the ep amplifier is not always fully restored when returning to the waveform display. intermittently the effected channel (s) becomes disconnected from the ep amplifier input pins leaving the input signal floating. the results in no curve displayed or the displayed curve (s) becoming distorted (noisy unstable).
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 possible defect in the rolling base of the natalcare st-lx incubator which could affect the safety of the 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.
Extra notes in the data
Reason
Testing of xsystems barbiturates ii u control lot 2811q100 found out of specification results high were observed for the low medium & high controls when the calibrator lot 33376q10 was used as the reference.
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
Catheters may contain ptfe beading material in the otw lumen that was placed during manufacturing but not removed prior to packaging.
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
Handpiece supplied with periowave system has potential for damaging the optical surfaces by overtightening of the optical coupler. there is a potential for diminished light transmission from handpiece.
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
Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which in turn can cause material in the rear endbell enclosure to overheat generate smoke in the scan room and cause some localized melting of the endbell.
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
Smith & nephew inc. has initiated a voluntary recall of the genesis trocar pin. a group of the trocar pins were distributed with incorrect expiration dates printed on the outer carton label. the manufacturing date was captured as the expiration date. the error is visually obvious to the user and the date is typically verified by hospital staff prior to 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
Abbott has confirmed that some kits of axsym valproic acid reagent lot 18439m503 have the potential to generate invalid calibration control or sample runs due to net intensity too low resulting in axsym instrument error code 1072. if the error occurs during calibration the curve will be invalid and recalibration will be required. if the error occurs during a control/sample run no results will be reported.
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
Synthes (canada) ltd. is initiating a medical device recall for the drill bit due to the potential for the drill stop to slip on the reamer. if the drill stop slips on the reamer it may cause deeper reaming than intended and in rare cases penetration of the joint space causing pain and/or joint irritation.
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
Printed circuit board malfunction may result in ventilator becoming non-functional with an unlikely possibility of no audible alarm sounding to alert caregiver.
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 lock nut used to tighten the wire within the distal jet device was missing the screw collar which serves as a mechanical stop to prevent over tightening.
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 cannula package has not been validated to a sterility assurance level (sal) of 0.000001 and therefore the sterility can not be assured.
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
Trinity biotech issued a customer notification letter stating that there had been a change to the low d dimer assigned range contained in lot numbers 113300 and 113301.
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
Increasing trend in complaints regarding cracks/damage to the balloon inflation hub.