Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Notes supplémentaires dans les données
Advice regarding the use of the device. 3rd Party Publications
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
R-d ject syringe - a device with a false ce mark.
Action
Please ensure that those responsible for the purchase of syringes are made aware of this issue.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Fda is alerting consumers and health care professionals of a nationwide/international recall of all medical devices labelled as sterile or ethylene oxide processed, manufactured by a&a of alpharetta, georgia. the firm also does business as a&a medical/rocket usa, and lifequest. some of the products manufactured by this company have been labelled and shipped as sterile but in fact may not have undergone any sterilization process. this has the potential of causing death or serious injury such as infection, infertility, and miscarriage. as a result, the company is recalling all products labelled as sterile and shipped nationwide and internationally to canada, egypt, italy and lebanon.
Action
Do not use any A & A Medical, Inc., Rocket USA, or Lifequest products. Please ensure that those responsible for the purchase of these devices are made aware of this issue.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The imb has been advised of several incidents with patients on long-term total parenteral nutrition using a broviac paediatric catheter. defects developed at a similar point on the catheter, where the hub separated from the catheter.
Action
The IMB advise that users of this product: Ensure that all staff dealing with broviac lines are advised of the incidents that have arisen with this device. Advise all staff and family members dealing with the device to carry out regular inspections of the device. Ensure that all staff and family members are trained in the use of the catheter. Ensure the device is clamped at the points indicated by the manufacturer in their literature. Report any indication of problems with the device to the Irish Medicines Board
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Failure of the handle on a patient monitor.
Action
Determine if you have these devices in use in your centre. Ensure that you have received the Advisory Notice that was circulated by the manufacturer. Ensure the manufacturer replaces the handles on the device. Ensure that all staff is advised of the potential problem with handling of heavy equipment. Ensure that local procedures emphasise the importance of care when lifting heavy equipment, particularly indicating not to lift heavy items over patients.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Fatal strangulation of two patients in germany when using the protection – blanket in bed.
Action
Determine if you have such devices in use in your centre. Examine the information for use provided with the device to determine if either the name or manufacturer detail match those provided above:
The device may be marketed in Ireland under an English name. The manufacturers name should be the same. Ensure that product is removed from use, labelled and quarantined. Contact the distributor from which you purchased the blanket and arrange for collection. Ensure that all relevant staff is advised of the potential serious risk of strangulation with such restraining products.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The measuring function of the syringe and the beaker are not in concurrence, which could result in a higher administered dose than intended. this product does not carry a ce mark.
Action
The IMB advises that you:
Ensure that all relevant staff are advised of the potential problem with this product. Cease selling this product. Quarantine any units that you may have in your possession. The quarantined stock should be returned to your distributor for disposal. Report any indications of problems with the device to the IMB.
Please advise the IMB of any stock that you have quarantined and returned.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Risk of accessories detaching from the main body of the hoist. all accessories used with these hoists are affected i.E. hoist boom, standing aid and seat.
Action
Advise Murray's Medical Equipment of the number and location of all affected devices in your health board area. Ensure the modification is carried out on all affected devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The potential for imaging problems ranging from artifact, sparking, vibration, patient discomfort and / or surface burns when the cervical halo device is worn during a mri scan.
Action
Ensure that all devices that are sold as single use devices are only use once Ensure that MRI compatible devices are configured and positioned in the MRI so as to ensure that they are not too close to the MRI core and that metal components are not criss-crossing or concentrated in one area Ensure that the use of all MRI compatible devices are reviewed when any changes are made to the MRI strength to ensure that they still remain compatible Ensure that patients screening forms are completed for all patients. (see form attached checklist) Report any indications of problems to the IMB
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Risk of electric shock: the mains input connector can be pulled out of the case exposing “live” terminals.
Action
Advise GE Medical Ireland of the number and location of all affected devices in your hospital / health board area Ensure the modification is carried out on all affected devices
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Recall of specified serial numbers of accessaed pad (model numbers 9100-0010-0 and 9100-0015-0), accessaed (model numbers 9100-0100-0, 9100-0100-1, 9100-0150-0, and 9100-0150-1), and accessals (model numbers 9100-0100-2 and 9100-0150-2) automated external defibrillator devices and discontinued support by the manufacturer of all other devices that are in use.
Action
Ensure that relevant all staff are advised of this Safety Notice. Ensure that all specified serial numbers listed below are immediately removed from use:
AccessAED PAD, AccessAED, AccessALS, serial numbers 075180 – 084760 Replace all other AEDs, not specified in the scope of the recall, as soon as possible
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The two above specified batches of condoms bearing the durex brand name are counterfeit products that do not meet the requirements of the european standard for condoms.
Action
The IMB advises that you: Check both the outer packet and the condom foil to see if the details given above are the same as those outlined on the product in your possession. If you have identified that you have product with the details above return any such affected product in your possession to your local pharmacy. If you think you may have used the affected condoms and have any health concerns, please consult your General Practitioner for their advice. Please be advised that this notice only applies to the 12 pack size of condoms specified above and not to any other pack size.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
These products do not carry a ce mark. the labelling of the condoms is in the chinese language and not in the english language as required by the national medical devices regulations.
Action
The IMB advises that you: Check if you have 'Tulip' condoms in your possession. If you have identified that you have these products you should dispose of these products immediately. If you think you may have used these condoms and have any health concerns, please consult your General Practitioner for their advice.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Incorrectly rated fuses in the iec socket were fitted to the above devices manufactured between 4th march 2005 and 12th may 2005 due to a vendor issue.
Action
Advise Oxygen Care Limited of the number and location of all affected devices in your institution. Ensure the modification is carried out on all affected devices.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
Notes supplémentaires dans les données
3rd Party Publications
Cause
Background information or related documents:
the irish medicines board is aware that bausch and lomb have:
voluntarily stopping shipment of all renu moisture loc solution manufactured at its facility in greenville, united states
advised retailers in the us to remove the renu moisture loc solution from their shelves temporarily
recommended that customers in the us switch to another lens care solution
this action was taken following multiple reports of fusarium keratitis among contact lens users in singapore, hong kong and the us. the bausch and lomb investigation into this issue is still ongoing and has not, to date, identified the cause of the problem. bausch and lomb have informed the imb that no renu moisture loc solution manufactured at the greenville plant is supplied to the european market.
bausch and lomb have indicated to the imb that the product supplied to the european market is manufactured at the bausch and lomb facility in italy. to date there have been no confirmed reported incidents of fusarium keratitis related to product manufactured at this european plant. this product is also manufactured in two other plants, in india and china. bausch & lomb have indicated that no confirmed incidents have been identified relating to renu moisture loc manufactured in these plants either.
as such, at this time bausch and lomb do not intend to stop the supply of product in europe.
the imb will continue to monitor the issue and will maintain close communication with bausch and lomb and other regulatory agencies.
recommendations:
the imb recommends that any irish customers who have purchased this product outside the european union or from an internet site should check the product label to determine where it was manufactured. irish customers should discontinue use of any product manufactured in the us and contact bausch and lomb if they have any concerns.
the imb recommends that contact lens users observe good contact lens hygiene practice and follow any recommendations provided by the manufacturer, their optician or other healthcare professional especially in relation to storage, cleaning and insertion of their contact lenses. contact lens users who experience eye symptoms such as pain, redness, excessive tear formation, abnormal sensitivity to light, blurred vision, discharge or swelling remove the contact lenses, discontinue use and consult a doctor.
the imb also recommend that healthcare professionals / clinicians with patients presenting with possible eye infections should consider fungal infections as a potential causative organism, investigate accordingly, preserve contact lenses and solutions for analysis, refer the patient if appropriate, and report contact lens related infections to the manufacturer.
bausch and lomb have set up a free phone number for irish customers 1800 409077. further recommendations and further information can be found on the bausch & lomb website
www.Bausch.Com
and on the website of the food and drug administration
www.Fda.Gov/bbs/topics/news/2006/new01354.Html
in the united states.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Recall of the sungift 500 battery powered scooters.
Action
Examine the scooters you have in your stock to determine if you have any Sungift 500 scooters. If you find one of these devices stop using it immediately, take it out of service and advise the Irish Medicines Board.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Replacement of rear wheel camber washers on avantgarde wheelchairs.
Action
The following actions should be taken: Ensure that prescribers / repair agents are made aware of this notice. Ensure that users of these devices are reminded of the importance of annual maintenance or service intervals.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Diagnostic kits for self-testing have been placed on the irish market by the above named manufacturer / supplier which do not meet requirements of medical device legislation and therefore pose a risk to public health and safety.
affected hiv test kits and chlamydia test kits have been found on the irish market. there is concern that the following affected kits may also have been placed on the irish market: syphilis, pregnancy, abo/rhesus blood typing, cholesterol and prostate specific antigen (psa) test kits.
this may have resulted in supply to pharmacists by celtic integrated network or to members of the public directly via www.Testdirect.Com or internet auction sites e.G. ebay.
the major issue of concern is that some of these test kits have been assembled from components of other kits that have been shown to be past their expiry date. there is also concern over manufacture, assembly and labelling of these kits in an inappropriate manner and in an unsuitable environment. this may result in supply to the market of test kits that do not perform as intended, and thereby pose risk to public health and safety.
the possible consequences of the use of these products include, but are not limited to: inappropriate/inaccurate results leading to misdiagnosis/undetected illness, lack of appropriate medical therapy and potential for transmission to others of undetected infectious diseases.
Action
Check to determine if you have purchased any of the above listed devices from www.testkitsdirect.com, Celtic Integrated Network or from internet auction sites If you have purchased these affected devices, check the packaging to determine if a CE mark is present, that they are not relabelled and that they are in date If you have concerns about your device do not use it and consult your doctor or pharmacist Pharmacies who have purchased devices from Celtic Integrated Networks or www.testkitsdirect.com which do not bear a valid CE mark or are over-labelled should cease supply If you have used an affected device and are concerned about your health please seek medical advice Caution is recommended if purchasing any medical device from an internet site or from a non-conventional supplier Always purchase medical devices with a CE mark and from reputable and recognised sources.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The wheelchair seat covers manufactured by invacare between february and october 2003 were supplied with a covering material, which did not meet the requirements for flammability defined by the manufacturer.
Action
Ensure that the purchaser and prescribers of these devices within your healthcare institution:
1. Identify all K-series, competition, compact, compact-hemi drive, kid and Ultra light seat covers that were supplied to your healthcare institution in 2003
2. Arrange with your supplier (Invacare Ireland or Lifestyle Mobility) to check the seat cover material. The inside of the non-flame retardant cover is black while the inside of the flame retardant cover is grey.
3. Ensure that all affected seat covers are replaced with new covers.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The food & drug administration (fda) issued a formal written request to shelhigh inc. to recall all its medical devices.
Action
Please ensure that all appropriate staff who are involved in the implantation / follow up of patients with this type of device are advised of the issue.
The FDA press releases and further information are available on www.fda.gov.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Lot hg0050 of the clearview hcg pregnancy test kit (cat number 500158) has been recalled by the manufacturer due to the potential for false negative results i.E. a negative result obtained in pregnancy.
Action
Action or Recommendations for Healthcare Professionals Ensure that all relevant staff in your institution are informed of this recall Determine if you have lot number HG0050 of the above product Locate and cease using product from lot number HG0050 Determine how much of this product has been used Follow the distributor / manufacturer recommendations for quarantine and disposal of product Follow up patients as required Action or Recommendations for Patients
Patients who have had a recent pregnancy test in hospital but are concerned that the negative result received may be incorrect should contact or seek a retest from their GP, family planning clinic or pharmacist.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The risk of severe freeze burns after use of scholl freeze verruca and wart remover.
Action
For your information to be aware of these changes Ensure all product contains new IFU and product livery Please ensure that the IFU are adhered to. In particular, the instruction for the correct application of the product
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
Brass bolt connecting the lift arm to the lifting actuator may fail if bolt wear is overlooked during recommended annual inspections.
Action
Advise Kjaerulff Rehabilitation A/S - Handicare A/S of the number and location of all affected devices in your institution. Ensure the modification is carried out on all affected devices.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
There is a possibility of a hole / tear forming in the expiratory limb of the circuit due to an external force, possibly by a circuit hanger / locator.
Action
Please ensure that you have received the advisory notice and advise Fisher & Paykel Healthcare on the number and location of devices via their response sheet Please distribute the advisory notice to all staff members who work with infant EVAQUA breathing circuits.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notes supplémentaires dans les données
Cause
The irish medicines board (imb) today confirmed that medtronic inc. has voluntarily suspended worldwide distribution of the sprint fidelis family of defibrillation leads and is recalling any unused leads because of the potential for lead fractures. the vast majority of sprint fidelis leads should continue to function normally; however, where a lead actually breaks, or ‘fractures’, this may result in an audible alert or may cause inappropriate shocks and / or loss of device function.
the imb are advising any patients who believe they may have a sprint fidelis lead to contact their cardiologists and seek medical advice.
following consultation with an independent group of experts, medtronic inc. are currently recommending that patients do not require automatic replacement of sprint fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture.
medtronic inc. has been in contact with cardiologists to inform them of the issue and provide them with follow up recommendations. medtronic inc. recommends against the further implantation of sprint fidelis leads (models: 6930, 6931, 6948, 6949). it is important to note that the sprint fidelis leads are not used with standard pacemaker devices but are used only with more specialist implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy – defibrillators (crt-ds) devices.
medtronic inc. has informed the imb that since october 2004 approximately 1178 sprint fidelis leads have been implanted in patients in 14 centres in ireland. the imb are advising any patients who believe they may have a sprint fidelis lead to contact their cardiologists and seek medical advice.
medtronic inc. is continuing to investigate the root cause of the lead fractures. the imb will continue to be in close communication with the manufacturer to ensure that this recall is conducted efficiently in ireland. recall of medtronic sprint fidelis defibrillation leads.