Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
[13 january 2012] field safety notice: terumo® advanced perfusion system 1
medical device manufacturer, terumo® cardiovascular systems corporation, has issued a field safety notice on the use of unauthorized cable for terumo® advanced perfusion system 1.
the manufacturer is aware of some users operating a terumo® advanced perfusion system 1 with a modified cable to connect the system to an occluder for the sarns™ modular perfusion system 8000. the cable is not specified for use with terumo® system 1 and its use in this manner constitutes an off-label use.
the modified cable is not compliant with terumo® system 1 specifications and its use may result in hazardous conditions such as easy dislodgement from the system base resulting in loss of the occluder’s function. it may cause the system to lose electro-magnetic interference protection or create a minor shock hazard in the event of an internal short/failure within the occluder system components.
according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: pneumothorax events associated with feeding tube placement systems
the united states food and drug administration (fda) issued a letter to the health care providers about reports of pneumothorax events associated with feeding tube placement procedures using the cortrak 2 enteral access system (eas) by corpak medsystems. most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. several of these events were associated with cardiopulmonary arrest and patient death. although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically < 0.5%, the fda is alerting clinicians that the use of this device does not eliminate this risk and reminding health care providers of important use information for eas systems.
from january 2012 to july 2017, the fda received 51 medical device reports (mdrs) about pneumothorax events related to the use of the cortrak device. these included 11 reports of patient death. the relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. in addition, because the mdr system is based on passive surveillance, the fda cannot determine how the rate of these complications compares to that estimated for blind insertion.
during that same period of time, fda received one report of a non-fatal pneumothorax event associated with the kangaroo feeding tube with iris technology. that event occurred following blind placement of the tube, without use of the video console. the smartrack device is not currently being sold within the united states and no mdrs have been received for this device. no mdrs have been received for the smartrack device this device.
for enteral access systems, the fda recommends:
the device only is used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
the device not be used in patients who have contraindications for naso-enteric feeding tubes in general.
if any resistance is met during placement or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed.
confirmation of the final tube position should be done per institution protocol, in particular if any difficulty occurred during insertion.
for details, please refer to the fda websites:
https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm591838.Htm
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/
ucm592051.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 15 january 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: meditech ultrasound gel
the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning ultrasound probe cover (telescopic folded with gel); and all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. [part number/ order code: 88654012; lot number: 201701].
meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia.
whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd. are also affected by this recall.
users are advised that all product labelled meditech and manufactured by yafho bio-technology co ltd and/or linmed medical co ltd, including all stock of ultrasound probe cover (telescopic folded with gel) should quarantined immediately and recalled from the market.
for details, please refer to the tga websites:
http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00631-1
https://www.Tga.Gov.Au/alert/meditech-ultrasound-gel
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 may 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: inferior vena cava filters
the health canada has issued a medical device alert concerning inferior vena cava (ivc) filters. the manufacturers, models and categories of the affected devices are as follows:
manufacturermodelcategory
‧a.L.Naln vena cava filterretrievable
‧bard peripheral vasculardenali vena cava filterg2 filter systemsimon nitinol vena cava filterretrievableretrievablepermanent
‧b. braun medicalvenatech lp vena cava filter systempermanent
‧cordis casheloptease vena cava filtertrapease permanent vena cava filterretrievablepermanent
‧rex medical, lpoption retrievable vena cava filter systemretrievable
‧william cook, europe aps and cook, inc.Cook celect platinum vena cava filtercook celect vena cava filtergianturco-roehm birds nest vena cava filtergunther tulip vena cava mreye filter setretrievableretrievablepermanentretrievable
as of june 6, 2016, health canada has received 121 incident reports of serious complications associated with ivc filters. these complications have also been reported internationally. serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with ivc filters. many of these complications occurred with long-term (greater than 30 days) filter implantation.
health canada has recently completed a review of the clinical evidence for the safety and effectiveness of ivc filters. although there have been numerous clinical studies of ivc filters, there are only two randomized controlled trials (rcts) of ivc filter use. in both studies, patients with documented venous thrombo-embolism (vte) were randomized to therapeutic anticoagulation alone or to therapeutic anticoagulation plus an ivc filter. results from these two rcts do not support the use of ivc filters in patients who can be treated with anticoagulation. reductions in vte and mortality have not been demonstrated.
health canada is communicating to healthcare professionals that ivc filters are appropriate for patients with certain types of blood clots, who cannot be treated with anticoagulant drugs. health canada is also working with the manufacturers of ivc filters to continue to monitor the post-market safety and effectiveness of ivc filters in canada as well as worldwide.
for details, please visit the following health canada website:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59518a-eng.Php
posted on 26 july 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: implantable left ventricular assist devices
the united states food and drug administration (fda) has issued a medical device safety alert concerning two implantable left ventricular assist devices (lvads). the affected devices are as follow:-
fda is alerting health care providers, patients, and caregivers about serious adverse events associated with lvads. these adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with thoratec’s heartmate ii and a high rate of stroke with the heartware hvad since approval of the devices. fda is also aware of bleeding complications related to both the thoratec heartmate ii and heartware hvad.
when used for the currently approved indications in appropriately selected patients, fda believes the benefits of these lvads continue to outweigh the risks. however, the fda also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.
for details, please refer to the fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm457333.Htm
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm457327.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 06 august 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: onetouch ultra 1x50 glucose test strips
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning onetouch ultra 1x50 test strips distributed by chemilines limited in the united kingdom. the affected batch number is 3621702/001 and the expiry date is oct 2015.
the distributor issued a voluntary recall on one batch of onetouch ultra- 1x50 test strips due to an error in the re-packaging process whereby wrong information input in the code box of the primary pack over-label.
the primary pack is covering the code on the original manufacturer’s label related to the reading accuracy of the result. that code should be input by the patient into the meter device for reading confirmation. as a result, the patient may experience difficulties using the product
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 december 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over genstrip blood glucose test strips
the department of health (dh) today (april 30) drew public attention to a safety alert concerning a glucose test strip called genstrip blood glucose test strips. the test strip, manufactured and sold by shasta technologies llc, may report incorrect blood glucose readings.
the dh, through its routine surveillance on medical devices, noticed the above alert issued by the us food and drug administration (fda). the test strips concerned are advertised for use with the lifescan onetouch family of glucose meters (e.G. ultra, ultra 2 and ultra mini) manufactured by another medical device manufacturer, johnson and johnson.
according to the alert, the fda found extensive violations of relevant regulations intended to assure the quality of products in the manufacturing of the test strips during a recent inspection of shasta technologies llc. as the company did not have in place many of the requirements of a quality system, the fda believes that the strips could report incorrect blood glucose levels.
a spokesman for the dh explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia.
the dh is investigating whether genstrip blood glucose test strips have been imported into hong kong. as the lifescan onetouch family of glucose meters is available for sale locally, there is also a possibility that some patients may have purchased the affected test strips abroad or from the internet for their own use. the dh hence advises the public to stop using the product concerned and switch to alternative blood glucose test strips which are designed for use with the lifescan onetouch family of glucose meters.
so far, the dh has not received any local report of adverse events arising from use of the product.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: mckesson anesthesia care system
the u.S. food and drug administration (fda) posted a medical device safety alert concerning mckesson anesthesia care system with code number mac 14.3.1/mac 14.3.1.1.
there was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record in that it included data from another case.
for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1060-2014&w=03122014&lang=eng
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 13 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over lenscare sh-system monatslinsen monthly contact lenses
the department of health (dh) today (november 19) drew public attention to the recall of lenscare sh-system monatslinsen contact lenses because the surface of these lenses can get scratches during wearing and can even break.
the dh, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a notice issued by a german manufacturer, 4care gmbh.
according to the manufacturer, customer complaints for certain lot numbers of the products have increased recently. it was found that the surface of the lenses can get scratches during wearing and can even break. this may lead to foreign body sensation, blurred vision or eye irritation. the manufacturer advised users to stop using the products immediately.
"the dh is following up with the manufacturer in germany to ascertain if the products have been distributed in hong kong. so far, the dh has not received any local reports of adverse events associated with the products," the spokesman said.
"those customers who have purchased the said products should stop using them. they should consult health-care professionals for advice as soon as possible if they are either feeling unwell after using the products or in doubt," the spokesman added.
the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed by medical industries australia
the therapeutic goods administration (tga), australia posted an medical device safety alert concerning sterile chlorohexidine gluconate/alcohol swabs, sterile alcohol swabs and sterile povidine iodine swabs distributed in the australia by medical industries australia pty ltd., a subsidiary of alpine medical pty ltd.
the swabs have been mislabelled sterile and sold on the market. this recall action was carried out prior to approval of the recall strategy by the tga.
medical industries australia is requesting wholesalers to return affected stock.
for details, please refer to tga websitehttp://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00887-1
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 26 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: sterile products from nuvision pharmacy
the united states food and drug administration (fda) has issued a press release to remind health care providers about safety concerns with all sterile drug products made and distributed by nuvision pharmacy of dallas, texas.
the fda advises that health care providers should not administer any nuvision pharmacy sterile products to patients because the products’ sterility is not assured. if the product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections
this alert follows the fda’s notice on 18 may 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for nuvision pharmacy sterile products, quarantine those products, and not administer them to patients.
according to the nuvision pharmacy’s website, injectables using higher strengths of hyaluronic acids in various delivery viscosities have been developed. the company also says that they can formulate products for wrinkle treatment (http://nuvisionpharmacy.Com/?id=13).
for details, please visit the following fda website:
http://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm365402.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: protac sensit chair
the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning the following sensit chair manufactured by protac a/s:
product no.: 600-601 standard model
product no.: 600-701 high model
product no.: 600-601-3500 standard model
product no.: 600-701-3500 high model
protac has heard that an over-excited child in the uk managed to get his head caught in one of the carrying straps on the protac sensit chair. as the strap sat around the child’s throat, he was unable to free himself. however, the staff managed to cut the handle so that fortunately nothing happened to the child.
to minimize events of this type from recurring, the manufacturer has implemented the following measures:
protac is sending a safety notice together with a warning (please note! take care to ensure the user’s head does not get caught in the carry straps.) to institutions and private customers who have purchased or who are using protac sensit chairs to draw their attention to this potential risk.
protac is also sending the safety notice with the warning to all foreign dealers in europe and australia, who must in turn inform their customers, institutions and private customers of this potential risk.
protac has redesigned the carrying straps on its protac sensit chair so that the new chair has new and safe straps.
protac advises the customers to assess the safety risk and implement any precautionary measures whenever necessary.
for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con286973
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 july 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: symbios medical products gopump and goblock rapid recovery system kits
the united states food and drug administration (fda) has posted a press release issued by symbios medical products concerning their gopump and goblock rapid recovery system kits.
according to the press release, the manufacturer initiated a voluntary recall of all gopump rapid recovery system kits and goblock kits manufactured with flow control components assembled prior to jul 2012. products subject to this recall were distributed between 1 apr 2011 and 30 apr 2013.
these products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.G., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
to date, there have been 5 complaints received, two of which involved serious consequences. there have been no patient deaths reported. the root cause is understood and processes have been put in place to address the issue.
for details, please visit the following fda website:
http://www.Fda.Gov/safety/recalls/ucm352627.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 may 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of multiload radiopaque cu375 intrauterine contraceptive devices (with photos)
the department of health (dh) today (march 26) instructed a local medical device supplier, merck sharp & dohme (asia) limited to recall one lot of multiload radiopaque cu375 intrauterine contraceptive devices (iucds), manufactured by an irish company, multilan ag, following discovery of impurities inside the packing of a number of devices.
the discovery was made by dh's family health service (fhs) when they conducted routine inspection of stock prior to distributing the devices for use by their maternal and child health centres (mchcs).
among some 300 iucds inspected belonging to lot number sm-3337-13, 4 devices were found to contain tiny hair-like or dust-like impurities inside their sterile pouches. so far, mchcs have not used iucds from the affected lot. the fhs reported the issue to the supplier as well as the medical device control office, which began investigation immediately.
according to the supplier, about 950 devices from the affected lot were distributed to public and private hospitals and some private clinics. the dh has not received any relevant report of adverse incidents in hong kong.
as a precautionary measure, the supplier is instructed to conduct a batch recall of the product with lot number sm-3337-13 from the market. the supplier has set up a hotline (3971 2913) for enquiries.
healthcare professionals should stop using the affected products immediately. dh has brought the matter to relevant stakeholders' attention and will follow up on the investigation.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: mle forearm crutch ergo grip (tall and adult)
the therapeutic goods administration (tga), australia issued a medical device safety alert concerning mle forearm crutch ergo grip (tall and adult) (batch number: 251097-1202-1, 251097-1203-1, 234354-1202-1, 234354-1203-1), distributed in australiaby making life easy mobility and independent living superstore.
a potential fault in the plastic component that links the arm cuff with the crutch stem in the affected batches has led to reports of the arm cuff separating from the crutch.
while no injuries have been reported, breakage of the plastic component during use could result in user injury due to a fall.
for details, please refer to tga websites:
http://www.Tga.Gov.Au/safety/
recalls-device-mle-forearm-crutch-121213.Htm and
http://www.Tga.Gov.Au/safety/
alerts-device-mle-forearm-crutch-121213.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 december 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: home aware home-use hiv and std test kits
the health canada has issued a safety advisory regarding online selling of unlicensed home-use hiv and std test kits for use with urine, saliva and blood samples on the website curaherbdistributor (curaherbdistributor.Com).
according to the health canada, curaherbdistributor's hiv kits carry the "home aware" brand and have not been evaluated by health canada for safety and effectiveness. in addition, curaherbdistributor is also attempting to sell online a number of other test kits under the "home aware" brand. health canada has not licensed "home aware" tests kits for any of the following conditions indicated on the website, namely syphilis, trichomonas vaginalis, gonorrhea, chlamydia, hepatitis (b/c) or herpes simplex.
health canada advised consumers to consult their healthcare practitioners if they have used any home-use test kits sold via the curaherbdistributor.Com website or under the "home aware" brand and are concerned about their health.
for further details, please refer to the health canada website:
http://www.Hc-sc.Gc.Ca/ahc-asc/media/advisories-avis/_2012
/2012_137-eng.Php
posted on 11 september 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: shanghai shenfeng l-gel ultrasound transmission gel
the australia therapeutic goods administration (tga) has issued a recall of all lots of l-gel ultrasound transmission gel manufactured between june 2011 and may 2012 by shanghai shenfeng, china. the gel is supplied in 250ml and 5l bottles.
the recall was initiated after tga tests found bacterial contamination (burkholderia cepacia, stenotrophomonas maltophilia and raoultella planticolla) in lot numbers 2011 06 17 to 2012 04 09 of the product. there is a small risk that patients who have been exposed to contaminated l-gel ultrasound transmission gel may develop an infection, this infection will usually be in the area where the gel was used.
stop using l-gel ultrasound transmission gel products with lot numbers 2011 06 17 to 2012 04 09.
identify patients who have been exposed to these lots of l-gel ultrasound transmission gel. review the procedures they underwent and the outcomes of the procedures, and take further action as necessary.
for details, please refer to tga website:
http://www.Tga.Gov.Au/safety/alerts-device-l-gel-120816.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of eukare blood glucose test strip the department of health (dh) today (march 5) drew public attention to the recall of certain lots of a blood glucose test strip, the eukare blood glucose test strip. the affected test strips may give falsely high blood glucose readings.
the dh noticed through its surveillance of medical devices that the product's manufacturer, eumed biotechnology co. ltd., has recalled two lots of the products (lot numbers: ts14dd1f1002 and ts16dd1h2814).
information from the manufacturer indicates that the problem appears to be related to improper storage of a reagent of the test strips.
a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia.
according to the manufacturer, the eukare blood glucose test strip has not been imported into hong kong.
so far, the dh has not received any local report of adverse events arising from use of the product.
"though the affected product has not been introduced into the hong kong market, and we have no record of related adverse events here, the possibility of individual diabetic patients having somehow obtained the product from abroad justifies a public alert, in our opinion," the spokesman said.
members of the public who may have the above test strips in their possession are advised to stop using the product and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai.
"for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman said.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: the nemschoff perinatal bassinet products (models: bsnt/01, bsnt/02, bsnt/03, bsnt/04)
the food and drug administration (fda), united states, has issued a class i recall on nemschoff perinatal bassinet products with models number of bsnt/01, bsnt/02, bsnt/03 and bsnt/04.
the manufacturer of the device, nemschoff chairs, inc, is correcting issues with casters, door hinges, drawer slides, and the bassinet surround of the affected devices. besides, nemschoff also adds labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
according to fda, the affected devices have been distributed in us and canada.
for details, please refer to fda website
http://www.Fda.Gov/safety/recalls/enforcement
reports/ucm292057.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: sierra scientific instruments manoshield™ ar
medical device manufacturer, sierra scientific instruments, is conducting a product recall for manoshield™ ar, part number mss-3599. the lot numbers affected are listed below:
lot number
f1114619ua
f1114625ua
f1115402ua
f1123703ua
f1128101ua
f1114620ua
f1114626ua
f1121304ua
f1124202ua
f1129701ua
f1114621ua
f1114627ua
f1123405ua
f1125201ua
f1130202ua
the recall is initiated because of quality defects found on some lots of the products. the, defects occurred during normal use, and were noted when product was used in a manner that was not supported by its design specification and tolerances. according to the local supplier, products with the affected lot numbers have not been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for further information and necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over lenscare sh- monatslinsen contact lenses the department of health (dh) today (december 7) drew public attention to the recall of certain lots of lenscare sh-system monatslinsen contact lenses because of the presence of small parts of silicone oil on the lenses.
a dh spokesman revealed that the department, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency (mhra) had issued a notice about the recall by the manufacturer, 4care ag, based in germany.
according to the manufacturer, they were informed by their production plant that silicone oil was found on certain lots of the contact lenses. this may lead to blurred vision, foreign body sensation or eye pain and so far, they did not receive complaints related to the incident. the lot numbers of the affected products are –
104350000200060215 104350000180050115 104350000120300115
104350000190090215 104350000210090215 104350000210050415
104350000190090215 104350000200100315 104350000240060315
104350000160220215 104350000200100315 104350000260080515
104350000110300115 104350000210140315 104350000250130315
104350000200060215 104350000170220315 104350000200190315
104350000190090215 104350000140230315 104350000140210415
104350000015190315 104350500000281114 104350000035180315
"the dh has immediately contacted the manufacturer in germany and found that the affected products have not been distributed in hong kong. although the affected products are not marketed in hong kong and we have no record of related adverse events here, the fact that there may be occasional users in the territory who have somehow obtained the devices from abroad justify a public alert, in our opinion," the spokesman said.
"those customers who have used the said product and are either feeling unwell or in doubt should consult their healthcare professionals for advice as soon as possible.”
the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue.
the spokesman added, "dh is aware that the use of contact lenses, including decorative lenses, is becoming increasingly common amongst the public. as the improper use of these lenses could seriously damage eye health, we would like to take this opportunity to remind members of the public on the proper use of contact lenses, especially as the festive season is drawing close and they may wear these lenses to parties or other social functions. before buying these lenses, consumers ought to consult their healthcare professionals. remove the contact lenses whenever you experience discomfort or redness of the eyes and seek advice from healthcare professionals promptly if symptoms persist. "
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: 4care ag’s sh-system monatslinsen contact lenses
the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on 4care ag’s monthly contact lenses “sh-system monatslinsen” due to the presence of small parts of silicone oil in some lots of the products. it may lead to blurry view or a foreign body sensation in the eye. sometimes it can lead to eye pain.
4 care ag is conducting a recall of the product.For details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: beavers dental la 5 burs
beavers dental is conducting a recall on la 5 burs. the manufacturer found that one lot of la5 burs actually contained fg 557 burs.
according to the manufacturer, there are no hong kong consignees affected by this recall.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: pentron clinical artiste nano-hybrid flowable composite
pentron clinical is conducting a recall on all production lots of artiste nano-hybrid flowable composite because the product is difficult to extrude.
according to the manufacturer, there are no hong kong consignees affected by this recall.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: beavers dental fg 1/2 burs
beavers dental is conducting a recall on one lot of fg 1/2 burs. according to the manufacturer, the call is being conducted as a result of a packaging error. the package labeled as fg 1/2 burs was incorrectly packaged with la 5 burs.
according to the manufacturer, there are no hong kong consignees affected by this recall.
if you are in possession of the affected products, please contact your supplier for necessary actions.