Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Asahi kasei medical co.,ltd. received a complaint in japan that patient's blood did not flow through some hollow fibers of the dialyzer. according to our investigation,it was conttrmed that some hollow flbers were clogged with the urethane resin.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
The investigation results showed that there were small breakages on hollow fibers in the returned
dialyzers, which caused blood leakage during the dialysis treatment with hemodiafiltration (hdf)
mode. note that these leakages occurred later than one hour after start of treatment, which means
that such broken hollow fibers would not have existed at the beginning of the treatment. further
internal investigation suggested that the broken hollow fibers were originated by the weakness of
the hollow fibers to the pressure strength in a small restricted portion.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
1.1 immediate activation of the keypad lock after closing the warning message window
in the case of an alert (eg >> filler collector <<, >> stuffed pipe ", etc.), the key lock has been disabled so that the user can confirm the alert message. the lockout was then left inactive for one minute so that the user could change the device settings. while observing the market, it turned out that some users or patients in this brief eas were unknowingly changing their device settings. based on this finding, the delayed activation of the keylock was canceled, so that the keylock is now activated again immediately after confirmation of the warning message.
1.2 optically highlighted start / stop key
the control area for starting and stopping therapy - the "start / stop" button on the touch screen - has been highlighted in blue in the software versions so far; after switching on the device or after stopping therapy, alternating switching between light blue and
dark blue indicated that therapy should be started again.
while observing the market, it was found that users of these opti- mers (alternating between light blue and dark blue) were not always detected and therefore therapy was delayed. therefore, the control area for starting and stopping therapy ("start / stop key") is now green. the switch between light green and dark green is now clearly distinguished from the 0d of the other parts of the control surface, which have always turned blue, so that the system catches the user's attention. the colors in the operating instructions that show this control surface have been modified accordingly.
1.3 changed intervals for intermittent operation
so far in the intermittent mode of operation it has been possible to set the wash interval from 1 minute to 10 minutes. at very short eas intervals (eg 1 minute of the highest cial negative pressure and 1 minute of the lowest target negative pressure),
in the case of detected leakage, the warning is withdrawn because the mode has changed with a short eas.
while observing the market, it appeared that some users had been misled by the display of a brief eas alert. therefore, the adjustable housing interval has been modified to allow users to set the desired target negative pressure between 3 and 10 minutes. the display of the detected status in the form of a warning is visible beyond eas.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Orion diagnostica has received complaints on quikfiead go wrcrp (146521, 146522) and
quikread go wrcfip+hb (146255) products. our investigations have shown that in rare cases the
tests of the below mentioned lots may give either erroneous cfip results or the measurement flow is
interrupted by the error message “faulty reagent addition". we are investigating possible effects of
improper use and storage of product and manufacturing process.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
In accordance with a decision taken by the french ansm authority, balt extrusion discontinues the production, marketing, distribution, export and use of sonic 1.5f micro-catheters and announces the recall of products with the references / batches listed below. indeed, the notified body was informed of the changes to sonic 1.5f, but it began to be marketed before the notified body formally endorsed the changes. these recalls apply only to sonic 1.5f and also to sonic 1.2f.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
There is a possibility that drug interferences from administration of
metamizole (dipyrone) to patients may generate false low results.
no customer complaint has been received for this particular issue. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Balt extrusion received a complaint about the presence of a clip marked “silk3.5x25” on
the dispenser of a stent leo 3.5x25 lot number # 00285285 (of. picture below). this issue
did not lead to any patient injury. nevertheless, as a precautionary measure, balt extrusion
implements a voluntary recall of the product leo 3.5x25 lot number # 00285285 (24 units) to
prevent any risk of mix-up during procedures.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Balt extrusion has recently received complaints regarding the bursting or inflating of sonic micro-catheters while injecting contrast fluids or embolizing agents.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
During the time period of jan 2016 – sept 2016 it has been determined through the complaint trending
program that the following laseredge surgical knives may have demonstrated higher than normal
complaints for dull knives. we are committed to ensuring that all of our products meet the highest
standards of quality and take matters such as this very seriously, which is why we are taking this action.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter is adding contraindication statements to address iodine allergy for baxter’s peritoneal dialysis products which contain iodine (i.E., povidone-iodine) or for which iodine use is recommended. the ifu will include instructions for users to not use the product if there is a known history of allergic reaction to iodine. the changes in the contraindication statements are not a result of a change in any of the products, but are a further enhancement of existing baxter labeling. see above for a list of product codes and descriptions. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter distributed an f sn (ref. annex 1 fsn fa—2014—010) in december 2014 to advise the user of the
possibility that foam may have formed in the venous blood line when the extracorporeal circuit was
primed using on—line priming. the f sn provided additional information on how to perform priming in
case the specific dialyzer in use generates foam in the venous chamber. the number of reports of foam in
the venous chamber significantly decreased with the application offsn fa-2014—010 recommendation
as a collateral effect of the same problem, i.E. residual air and foam after priming, it has been observed
an increased probability of air alarms occurrence. it has to be clarified that air alarm is not a risk in
itself and is intended to prevent infusion of air which might be dangerous to the patient. this alarm stops
the blood pump and interrupts the treatment until resolution by the user.
in some cases it was reported that a few minutes after resolving an occurrence of air alarm and restarting
the blood pump the patient experienced symptoms commonly repofied as hypotension. this typically
followed a prolonged blood pump stop associated to a problematic air alarm troubleshooting.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation (to be adapted locally) is initiating a field action
in order to update software versions of the prismaflex control unit. baxter has
received reports of device operators failing to adhere to the instructions for
use pertaining to the safe unloading of disposable sets from the prismaflex
control unit. these steps are required to safely disconnect the patient before
proceeding to unload the filter set after treatment. if not followed, severe blood
loss may occur with a potentially fatal outcome. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation (to be adapted locally) is issuing a device
correction for specific models of the artis/evosys dialysis systems in order to
update the current software versions to new software versions. the current
version allows for the possibility of resetting and continuing patient treatment
without following the instructions for addressing alarm #642, “arterial
chamber: level adjustment required.” this will subsequently deactivate the
alarm for the remaining treatment time. the new software versions prevent
the possibility of continuing the treatment without following the instructions for
addressing alarm #642, as written in the operator’s manual. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation has been advised that users may not follow the instructions in the user's guide and incorrectly open the pack of disposable kits when preparing to perform peritoneal dialysis (pd), thereby damaging the homechoice or homechoice pro cassettes.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation issues a voluntary recall of the hemodialysis conventional product line with the above product codes and batch numbers due to customer complaints regarding fracture of the pre-dialysis artery expansion chamber at various stages of treatment. following an investigation, baxter found that there had been a change in the formulation of the material which could have led to increased material fragility and reduced impact resistance.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter is issuing a safety alert communication to inform customers of the
potential for disconnection of the artiset bloodline (luer of arterial and/or
venous patient connector) from the patient access site (needle/catheter)
during treatment. baxter has identified a potential for increased likelihood of
disconnection during post-market surveillance activities. the arterial and
venous patient connectors are designed in compliance with the applicable
international standards iso594 and iso8638, allowing safe connection to
vascular accesses. the post-market surveillance reports of disconnection of
the artiset bloodline from the patient access site were caused by the
healthcare provider improperly connecting the two devices. to address this
issue, baxter is providing additional instructions on how to properly connect
the devices. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation is voluntarily recalling one lot of ultrafilter (product
u9000, lot 6-1804-h-01). the manufacturing team noticed the potential of defective
filters based on an improper molded hansen lock. the reported issue is specific to this
one lot and others lots not impacted. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
We have found that all valid sas kits used with the medrad® intego pet injection system can produce particles in radiopharmaceutical (rp) vials when inserting a needle. these particles can occur when the needle tip penetrates the rubber septum on the vial. this poses a potential safety risk for the particle (s) injected into the patient.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
For women requiring the insertion of an essure medical device and endometrial ablation, there is an increased risk of certain events known to be associated with particular procedures. with this notification, we would like to inform you that the instruction for use (lfu) will be updated shortly.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
We are contacting you to provide important information about a voluntary field corrective action regarding the use of contour®next control solutions with the contour®next family meters (contour®xt/next ez, contour®next, contour®next link, contour®next link 2.4, contour®next usb), medtronic minimed paradigm insulin infusion pumps (models mmt-512, mmt-712, mmt-515, mmt-715, mmt-522, mmt-522k, mmt-722, mmt-722k, mmt-523, mmt523k, mmt-723, mmt-723k, mmt-551, mmt-751, mmt-554 and mmt-754), minimed ngp pumps (models mmt-1510, mmt-1511, mmt-1512, mmt-1580, & mmt-1712), medtronic minimed guardian monitor real-time (models css7100 & css7200) and contour®next test strips. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Our investigation indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an “rp prime failed. check sas and vial installation, then reprime.” error message. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Through complaints, angiomed has identified products with the combinations of markings and batch numbers listed in annex 1 that may contain a mandrene cap at risk of breakage. if the mandrene cap broke, the user had to remove the needle and re-insert the new needle to complete the biopsy, or abandon the biopsy completely due to certain unforeseen circumstances.
our records show that your establishment has purchased one or more units of affected products with combinations of labels and batch numbers. all other products with combinations of markings and batch numbers not listed in the safety corrective action notice may continue to be used at your establishment because they are safe to use and are not subject to this product recall.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
Bard has received complaints of low flow associated with certain batches of arcticgel ™ pads.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notes supplémentaires dans les données
Cause
The tag supplement provides advice that regular maintenance and maintenance of the arctic sun® 5000 temperature monitoring system is recommended to reduce the likelihood of failure of certain components.
this letter also details the preventative maintenance program offered by bard to assist in the regular servicing and maintenance of the device.
this is not a product recall, and bard does not require you to withdraw from the market and return any unit as a result of this notice.