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.
Extra notes in the data
Reason
Synthes received several complaints that the clamps could not be connected with the
transpedicular schanz screw, because in some cases, the shaft of the screw is too
thick.
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.
Extra notes in the data
Reason
Through internal investigation synthes identified the potential for non-conforming helical
blades to be distributed to the field. helical blades, which are part of the tfn system, may
have one or more dimensional features out of tolerance. the potential features that may be
out of tolerance include the inner diameter of the helical blade where the guide wire passes
and the dimensional features that allow for the helical blade and insertion instrument to mate.
these non-conformances are not immediately apparent and the following is a summary of the
potential outcomes that could occur if a patient is exposed to non-conforming product.
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.
Extra notes in the data
Reason
Lntegra lifesciences corporation (lntegra) has identified that there is a possibility that some customers
received a camino® advanced monitor (camol), in which the optional sys/dias mode displays
reversed systolic and diastolic intracranial pressure (icp) values.
the camino® advanced monitor is a compact. portable device displaying intracranial pressure,
intracranial temperature (ict), and calculating cerebral perfusion pressure (cpp).
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.
Extra notes in the data
Reason
The guide wire 0 3.2 mm. length 400 mm included an incorrect raw material listed on the label.
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.
Extra notes in the data
Reason
The purpose of this letter is to advise you that focus diagnostics is providing an urgent safety
notice for a correction to the labeling for simplexa™ flu a/b & rsv direct (mol2650) and
simplexa™ hsv 1&2 direct assays (mol2150). focus diagnostics received some customer
complaints of simplexa flu a/b & rsv direct assays with sporadic false signals, which may
result in a higher false results rate due to a potential software spectral matrix and direct
amplification disc storage. to date, focus has not received any complaints for the simplexa
hsv 1 & 2 direct assay used for commercial use. focus diagnostics is not requesting removal
of any products from the test facility, but you should take extra precautions as described in the
updated labeling. .
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.
Extra notes in the data
Reason
Focus diagnostics inadvertently shipped to your facility 100 chlamydia mif slides (if1201)
ln# 23858 that did not complete release testing.
.
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.
Extra notes in the data
Reason
There are potential harms associated with the distal aiming arm not being manufactured in
accordance to the specifications.
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.
Extra notes in the data
Reason
The packaging of the mentioned lot of the headless compression screw (a 6.5 mm, self—
d ng, cannulated, length 80/32 mm, stainless steel, sterile contains a titanium screw
(golden) instead of a stainless steel (silver) screw.
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.
Extra notes in the data
Reason
Siemens has determined that an error may occur when transferring patient demographics from the advia centaur xp analyzer to the lis. it has been found that in very rare cases, patient demographics from a previous order sent from the lis are transferred or attached to the next order. this problem can occur when the lis buffer in the advia centaur xp analyzer becomes full, and / or when a specific one character is found in the lis buffer in the last 5 positions. in this case, the patient's demographic information will be transferred to the lis and displayed on the advia centaur xp analyzer as well as on the printouts.
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.
Extra notes in the data
Reason
This action is being initiated as a result of alere’s post market surveillance activity. specifically, negative results were obtained from a single sample in the eqa ring trial in europe. this sample was taken from a 40 year old man with a 7 day history of fever, rash and fatigue and contained p24 antigen of a virus of subtype c at a concentration of 250 pg / ml (viral load of 2,500,000 copies / ml), corresponding to 50 iu / ml (who standard). a recent publication of a survey conducted in swaziland also suggested that the antigen component of the alere determine hiv-1/2 ag/ab combo test in a high-prevalence, high-incidence setting was unable to detect acute infection in this subtype c population (yen t. duong et al., j. clin. microbiol. 2014, 52(10):3743-3748). .
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.
Extra notes in the data
Reason
As part of unomedical a/s product quality monitoring process, we identified an increase in reports of the
tubing becoming detached at the connect/disconnect location on the infusion sets comfort, comfort short and
contact detach (please see images below). while the number of these reports remains low, we are notifying
you of this potential issue because your safety and experience with our products is our top priority. if tubing
detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify you. the interruption of
insulin delivery can cause hyperglycemia, which if left untreated, can result in diabetic ketoacidosis (dka).
dka is a serious condition that can cause a severe impact to health, including death. symptoms of dka may
include nausea, vomiting, shortness of breath and excess thirst/urination. seek medical attention immediately
if you are experiencing any of these symptoms. .
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.
Extra notes in the data
Reason
Teleflex medical is recalling the product referenced above due to a labelling inconsistency. teleflex medical has received complaints that the labelling of units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube. it is unlikely that the mislabelling will result in any serious adverse health consequences; however, it may cause difficulty in obtaining a proper seal between the device and the patient, possibly necessitating reintubation of the patient and resulting in a delay in treatment. teleflex medical is recalling the affected lot in an effort to provide our customers and their patients with the highest quality product possible.
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.
Extra notes in the data
Reason
Through the investigation of a single complaint, integra lifesciences corporation (integra) has identified
that there is a possibility that pt02 readings may be underestimated due to an incorrectly programmed
smart card when using some lots of licox® probes (references listed above).
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.
Extra notes in the data
Reason
The affected lots of the bending/cutting pliers with nose for lock plates 2.0 have the
potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates
(part numbers 447.412, 447.420, 447.422, 447.423, 447.424, 447.425, 447.426, 447.4128,
447.4208, 447.4228. 447.4238 447.424 s, 447.425 8 and 447.4268 ) with the last hole
feature of the instrument.
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.
Extra notes in the data
Reason
Radiometer has recently become aware of a potential significant clinical issue with the results reported if or when the inlet is left open after aspiration of the patient sample, for more than 30 seconds.
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.
Extra notes in the data
Reason
Trumpf medical has received reports that in some cases the above operating tables were moving automatically and without conscious use of the remote control. no injuries to patients or users. reported cases suddenly occurred during preparation or surgery.
through individual investigations, each time it was determined that the problem was a button on the remote control that was mechanically damaged by external influences. the defective key corresponded to the reported direction of movement each time. key injuries may have occurred due to e.G. collision with other objects or compression between moving parts. as a result, the remote control can, at any time, permanently or temporarily transmit a movement command at a time when a particular shake or movement occurs. the operating table cannot differentiate the throw with such and the desired movement commands. based on investigations, trumpf medical has determined that remote controls were used
controls that show clear damage and are therefore no longer permitted to use. automatic movement can be prevented by proper inspection before use.
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.
Extra notes in the data
Reason
There is a lack of proof of material biocompatiiity for the insert for dhs/dcs lmpactor no.
338.280. single (part number 338260) used in the existing product (lots specified)
(polyamide 6.6 with 20% carbon fiber reinforcement. tecamid 66 cf 20). no compatibility
testing has ever been completed by synthes for this material and no evidence was found that
it has been completed by other entities.
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.
Extra notes in the data
Reason
Customers complained about a 20% decrease in control levels when using non-roche controls (e.G. thermofisher liqimmune) with homocysteine reagent lot 697811 on cobas c 501. after changing to lot 604303, the controls were within range. the comparison of patient samples with reagent lot 697811 vs 604303 showed a bias of up to 54%. edta plasma samples were used. this negative bias could, in the worst case, lead to inaccurately low homocysteine results. however, it is unlikely that inaccurately low homocysteine results would lead to an immediate adverse event, since it has been demonstrated that homocysteine is a predictor of long-term (late cardiac events), rather than short-term cardiovascular risk. .
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.
Extra notes in the data
Reason
As a precautionary measure, zimmer gmbh is initiating a voluntary recall of certain batches of
the above referenced revitan proximal spout stems (size 55-105) and revitan proximal
cylindrical stems (size 55-105), because the thread spacing of the products might be out of
specification.
during the annual recalibration process of an inspection tool (thread plug gauge), used for a
process control during manufacturing of the revitan stem threads, it was detected that the
inspection tool was out of specification. .
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.
Extra notes in the data
Reason
Device software treatment
preset parameters do not match the operator manual, and
exceed recommended settings. operator manual parameters
are lower than indicated for specific hair color and fitzpatrick
skin type resulting in insufficient treatment effect. experienced
device operators who have an understanding of fitzpatrick skin
typing, hair removal parameter selection and lightsheer
products will likely note the higher than expected treatment
settings displayed by the system for the xc treatment
handpiece. if the device operator references existing
lightsheer desire operator manual the settings noted will be
lower than expected. selecting settings from the desire
operator manual would result in no or low treatment effect.
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.
Extra notes in the data
Reason
Siemens diagnostics have identified the possibility of false elevations in advia® chemistry
lipase assay analyzers, because of the possibility of transferring reagents and carryover from one or
which of the following tests: triglycerides, triglycerides_2, concentrated triglyceride reagent,
concentrated cholesterol reagent and direct ldl. .
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.
Extra notes in the data
Reason
Labelling failure was detected for lot 50057103 only.
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.
Extra notes in the data
Reason
Biocompatibles uk ltd. (manufacturer) sends this message to inform you that conflicting labeling has been used for certain sizes of the medical device bead block ™ (embolic bullet). this notification is not due to an increase in complaints or adverse events associated with bead block ™. make sure that all potential users at your institution are made aware of this notice and the recommended actions.
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.
Extra notes in the data
Reason
There is the potential that the tfna nails received before march 31, 2015 from the affected
lots were assembled with a locking mechanism too close to the top of the nail.
the locking mechanism could:
. prevent the connecting screw from fully tightening the insertion handle to the nail
resulting in a loose or toggling nail in the insertion handle, or
. cause the bottom of the connecting screw to tighten against the top of the locking
mechanism preventing advancement of the locking mechanism.
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.
Extra notes in the data
Reason
Specific immunoglobulins can cause an interference with d-dimer gen. 2 assay in rare cases. the interference may depend on the immunoglobulin level and/or the structure of the immunoglobulin molecule itself. the current wording in the package inserts is correct but only related to gammopathy and needs to be extended in order to cover other types of immunoglobulin interferences.
.