"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 manufacturer, ev3, has advised the irish medicines board (imb) of a recall of specific lots of the intrastent unmounted balloon expandable stent.
the manufacturer has confirmed that the following affected lot / serial numbers have been supplied to the irish market:
4206244, 1688027, 1979986, 3003378.
Action
Ensure that the relevant personnel in your organisation are made aware of this recall. Determine if you have purchased the affected lots of this product. Quarantine and return any unused affected product to ev3, United Kingdom office (see address below). Advise the IMB if you have the affected 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
The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.
Action
Further to this incident the Irish Medicines Board (IMB) advises users to discontinue the use of the device until further notice. Identify and quarantine affected devices until further notice. If no alternative fluid warmer is available, ensure users are aware of the advice provided in the manufacturer’s customer letter (copy attached as appendix 1) and ensure that the quick reference guide is attached to all affected devices. Contact the manufacturer to request a copy of quick reference guide if not attached to 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 irish medicines board (imb) have been alerted that the ‘baby beets fetal doppler’ is not officially ce marked and therefore may not reach the required standards of safety and quality, as required by the medical device legislation. this product may have been purchased through the internet.
Action
Check if you have a Baby Beets Fetal Doppler in your possession. If you have determined that you have this product, you should discontinue use immediately. If you have any health concerns, please consult your doctor (General Practitioner, Gynaecologist or Obstetrician) for their advice. If you are selling this product, stop, quarantine the product and contact the IMB immediately.
"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
A number of incidents have been reported to the irish medicines board (imb) relating to the use of these frames. this purpose of this notice is to: make users / prescribers aware of a quality improvement / design change implemented by the manufacturer in july 2006. ensure that the instructions for safe and effective device use are communicated.
Action
Ensure users / prescribers are aware of issues Familiarisation with the instructions for safe and effective device use, in particular the general safety and warning statements in the manufacturers’ instructions for use. Ensure that device is in proper working order before being put into service as these frames can be damaged during shipment or storage. Highlight to users the need for regular inspection of the device for damage or signs of wear in accordance with manufacturers guidelines and where necessary to take appropriate remedial action (in the form of replacement / repair).
"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 97552 and lot 97574 of the clinitest hcg pregnancy test kits 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 97552 and lot 97574 of the above product Locate and cease using product from lot 97552 and lot 97574 Determine how much of this product has been used Follow the distributor / manufacturers 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 mhra in the united kingdom have issued a medical device alert (mda/2009/021) concerning counterfeit novofine 31g insulin pen needles, 0.25m x 6mm in circulation in the united kingdom. it is highly unlikely that the counterfeit needles have been manufactured to the appropriate standards. the insulin used including the pen injection device is not affected. to date, there is no evidence that these counterfeit products have been placed on the irish market. lot number 08j02s is the only affected lot number. there is no genuine product on the irish market with the same lot number. as a precautionary measure, the imb are requesting that consumers and pharmacies check the lot number on the protective tab for the needle and on the carton label for the affected lot number. the imb are advising pharmacies to examine their stock and immediately cease sales of lot number 08j02s. should consumers have any of the counterfeit needles, the imb advise consumers to return any affected product to their local pharmacy and those with health concerns should consult with their general practitioner. please notify the imb immediately if you have any novofine needles 31g, 0.25m x 6mm, lot number 08j02s. the imb will continue to monitor this issue closely along with our colleagues in the united kingdom.
"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 patients and healthcare professionals to be injured by catching their fingers at various pinch-points on the exact couch top. a number of incidents occurred since the distribution of a field safety notice (fsn) highlighting the issue.
Action
Ensure that FSN (reference CP-00019) supplied by Varian Medical Systems is circulated to all users of the Exact couch top. Report any incidents 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
Spacelabs healthcare issued an ‘urgent – medical device correction’ letter in august 2008 advising all customers of several circumstances where the device alarm may fail.
Action
Ensure that the appropriate personnel are made aware of this notice. Advise Hospital Services Ireland of the number and location of all affected devices in your hospital / health board. Ensure that the software upgrade is completed on all 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
Non-compliant and inaccurate (up to 0.5°c) aid fast, 1st aid and powerplast digital thermometers have been provided to discount outlets in ireland. these digital thermometers are not appropriately ce marked. these thermometers may be marketed under a variety of brands and the packaging may vary.
Action
Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices branded Aid Fast, 1st Aid or Powerplast digital thermometers. If you find that you have these products cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance. Also, should you discover any other similar brands of digital thermometers that do not clearly identify the manufacturers name and address on the packaging, please advise the IMB. Advice for Consumers Consumers should check their digital thermometer to determine if their device is branded Aid Fast, 1st Aid or Powerplast. If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
"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
Non-compliant ‘first steps’ medicine feeders have been provided to retail outlets in ireland by rsw international limited. these medicine feeders are not appropriately ce marked.
Action
Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range.
If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.
Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB. Advice for Consumers
Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range.
If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
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:
boston scientific corporation is conducting a medical device recall of the leveen™ needle electrodes – 5.0cm. boston scientific has become aware that during a procedure, the umbrella of the leveen™ needle electrode – 5.0cm may become detached from the core wire. the potential clinical effects of this product issue are bleeding or soft tissue trauma which may require intervention. to date there has been one reported complaint for this issue.
further information is available in the field safety notice below.
important safety information - leveen needle electrodes – 5.0cm.
"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
Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
Action
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Contoura 880 beds.
3) Determine if your institution has devices affected by this issue.
This can be determined by:
A) Checking the manufacturing date to see if it is between December 1999 and June 2001.
B) Checking if the Serial number lies in the range 167386 to 382938.
4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.
5) Ensure that correction is completed 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 optium xceed blood glucose meter (manufactured by abbott diabetes care) or boots brand blood glucose meters, may generate incorrect results when used in conjunction with the onetouch ultra test strips, manufactured by lifescan.
Action
The IMB recommends that users follow the manufacturer’s instructions for use and User’s Guide to determine which blood glucose meters and test strips are compatible.
Table showing compatible meters and test strips Manufacturer Meter Compatible test strip Abbott Diabetes Care Optium Xceed Optium Plus test strips
(foil wrapped) Boots Boots Brand Optium Plus test strips
(foil wrapped) LifeScan OneTouch Ultra
OneTouch Ultra 2
OneTouch UltraEasy
OneTouch UltraSmart OneTouch Ultra test strips Pharmacists supplying OneTouch Ultra test strips and Optium Xceed or Boots brand meters: If you supply Optium Xceed or Boots brand meters you should advise the user to only use Optium Plus test strips. When you dispense OneTouch Ultra test strips you should advise the user that these test strips are only intended for use with the OneTouch Ultra brand meters. GPs prescribing blood glucose meter test strips: Only prescribe Optium Plus test strips for use with Optium Xceed or Boots brand meters. Only prescribe OneTouch Ultra test strips for use with OneTouch Ultra brand meters. Healthcare professionals managing patients who use the affected devices: Advise patients to ensure that they are using the correct test strips for their meter as described in the meter’s user manual.
Healthcare professionals who use these devices: Ensure that Optium Plus test strips are only used with the Optium Xceed or Boots brand meters. Ensure that OneTouch Ultra test strips are only used with the OneTouch Ultra brand meters. General public: Only use Optium Plus test strips with the Optium Xceed or Boots brand meters. Only use OneTouch Ultra test strips with OneTouch Ultra brand meters. Please bring this safety notice to the attention of all who need to be aware of it. This will include further distribution to:
Accident & Emergency Departments
All wards
Ambulance services directors
Ambulance staff
Biochemists
Chief pharmacists
Clinical pathologists
Clinical pathology directors
Day surgery units
Diabetes clinics / outpatients
Diabetes nurse specialists
Hospital pharmacists
Medical Directors
Nursing executive directors
Outpatient clinics
Outpatient theatre managers
Outpatients theatre nurses
Pharmacists
Point of care testing co-ordinators
Risk managers
The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the website.
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:
roche has confirmed a problem with k-tips (m/n: 03287343001), lots 09001108, 09002108, 09003108, 09004108, 09005108, 09006108, 09007108, 09008108 and 09009108, which are for use with the cobas® ampliprep instrument. the affected lots contain k-tips that are completely closed (near the pipetting end of the k-tip), which prevents the cobas® ampliprep instrument from pipetting eluate from the spu into the k-tube. roche has confirmed that use of these defective k-tips will result in an invalid run and no reportable results. roche is recalling all affected lots.
further information is available in the field safety notice below.
important safety information - k tips
note: field safety notices are placed on our website for information purposes. you will not normally need to take further action unless the manufacturer has contacted you directly or we have issued additional 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
Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
Action
Advice for Retailers and Wholesalers
(1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.
(2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.
(3) Ensure the appropriate personnel are made aware of this notice. Advice for Healthcare Institutions / Consumers
(1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.
(2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.
(3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.
(4) Ensure the appropriate personnel are made aware of this notice.
"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 zoll aed plus defibrillator may not deliver therapy.
Action
1. Ensure that the relevant personnel in your organisation are made aware of this issue.
2. Determine if you have purchased the affected serial numbers of this product, AED Plus devices with serial numbers below X_ _ _200000.
3. If you have an affected device confirm that the recommended actions have been completed:
Ensure that the date when the batteries were installed in your device has been checked.
a. If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the label provided by Zoll showing the next scheduled replacement date. Read and add the addendum incorporating this information to the administrator’s guide that was provided by Zoll.
b. If batteries are not more than three (3) years old, add the label provided by Zoll completed with the next scheduled replacement date. Read and add the addendum, provided by Zoll, incorporating this information to the administrator’s guide.
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 a software upgrade. 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
A manufacturing problem has been detected where under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimum temperature delivery to the treatment site.
Action
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Wallach LL100 Cryosurgical System CO2 and Accessories.
3) Follow the instructions outlined in the attached FSN from Wallach Surgical regarding this action.
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
Abbott has determined that s/co values generated with architect anti-hcv (ln 6c37) may decrease when 25% or less of test volume is remaining leading to:
• abbott positive control values shift down and/or out of range low, • non-abbott positive control values shift down and/or out of range low, and/or • a decrease in patient result values.
Action
Abbott has issued a Field Safety Notice (FSN) (March 2010) to all Irish customers using the ARCHITECT Anti-HCV assay recommending customers mix the ARCHITECT Anti-HCV assay diluent (LN 6C37J, green bottle label) prior to testing each day of use.
"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
Certain philips respironics humidifiers may present a risk of potential burn if handled while exhibiting thermal deformation due to a connector failure. this is due to an intermittent connection between the heater plate and the printed circuit board which results in a blinking led on the humidifier control knob.
Action
1) Ensure the appropriate personnel are made aware of this notice.
2) Identify the location of all Philips Respironics M Series Heated Humidifiers.
3) Determine if your institution has devices affected by this issue (check the serial numbers).
4) Examine the humidifier control knob for a blinking blue light as shown in the attached field safety notice issued by the manufacturer.
5) Ensure that corrective action is completed 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
Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.
Action
• Ensure the appropriate personnel are made aware of this notice.
• Ensure that the patient follow up recommended by the manufacturer is followed (please see above).
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 a device removal. 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
Advice regarding a device modification. 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
The potential supply and use of a counterfeit haemorrhoidal circular stapler product called proximate® pph procedure for prolapse and hemorrhoids set, product code pph03, from the above batch that is not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
Action
The IMB advises that:
All product in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.
• If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local EES representative, JOhnson Ireland, who will be able to confirm if the product is authentic.
• If you identify that you have product that is counterfeit you should return any such affected product in your possession to
Johnson & Johnson Ireland, and inform the IMB.