Tag: mhra
Stanmore hip implant recall
The Stanmore hip implant recall published earlier this year relates to the potential for some Modular Femoral Heads being contained in the incorrect packaging.
The urgent Field Safety Notice issued by Stanmore Implants – who are a part of the Stryker Corporation – outlines the issue and the potential dangers. It may be that patients could be fitted with the incorrect implant heads if the problem is not identified by surgeons and medical staff at the time of an operation.
As with most medical implant problems, this recall is a serious matter, and we have seen the damage that can be done to patients when things go wrong with hip implants.
Ethicon surgical staplers medical device alert
A medical device alert has been issued and published by the MHRA in relation to Ethicon surgical staplers, which have reportedly caused injury to some patients.
It’s understood that there’s a risk that some of the devices manufactured from March 2018 have not been working properly. Reported issues include the devices misfiring or failing to fire the staples during surgery. The MHRA (Medicines and Healthcare products Regulatory Agency) say that there has been increased complaints of malformed stables with some devices being returned.
With this issue involving invasive surgery, the alert is one that needs to be taken incredibly seriously.
Knee replacement bearing recall
A knee replacement bearing recall has been initiated by Biomet UK Limited after the discovery that there’s a risk of some of their bearings being placed in the wrong packaging.
According to the available Field Safety Notice published by the MHRA (Medicines and Healthcare products Regulatory Agency), left-handed bearings may have been placed in packaging for right-handed bearings. The discovery was reportedly made after a complaint had been received, and the recall that has been put in place affects products distributed this year.
Recalls involving medical devices and medical implants can be quite common. In some cases, the risk of any actual harm to patients is relatively low. However, in some instances, the problems that people can suffer with can be severe.
Raindrop near vision inlay recall
The Raindrop Near Vision Inlay recall has been initiated due to an increased risk of corneal haze that patients implanted with the devices may experience.
A Medical Device Alert was issued via the MHRA (Medicines and Healthcare products Regulatory Agency) a few weeks ago. There’s a warning to not implant Raindrop Near Vision Inlays and to dispose of any unused stock of them.
Any patients who have already been implanted with the inlays are to be monitored, and any incidents and problems are to be reported. This recall follows the recent news coverage about the Oculentis recall, which is one of the compensation actions we’re representing people for.
Valsartan recall widens
The Valsartan recall widened last month following updated advice from the Medicines and Healthcare Regulatory Authority (MHRA).
Batches of products containing Valsartan that were supplied by Teva UK Ltd and Mylan are being recalled in the UK. This follows on from a drug alert earlier this year that was issued after the discovery that some Valsartan products were contaminated. Legal cases are already underway, and this latest recall involves further batches of the product.
An immediate suspension and quarantine of the additional affected products has been ordered.
Were you affected by the cough syrup mould recall?
Were you affected by the cough syrup mould issues that came to light over summer? In the midst of the season for colds and coughs, you may want to take heed of this warning if you’re not aware of it already.
Over summer, a formal recall was issued with the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency. This was a Class 2 Medicines recall for own-brand glycerine and blackcurrant cough syrup products manufactured for children by Bell, Sons & Co.
As these are marketed as own-brand products, it’s the likes of Asda, Morrisons, Sainsbury’s and Tesco at the centre of this recall.
Bone cement complications from product recall
A regulator warning earlier this year stemmed from bone cement complications caused by an issue with the product itself.
A risk of the need for revision surgery from the use of Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision was identified. Manufacturer, Biomet UK Limited, issued a Field Safety Notice at the end of last year. The UK’s medical regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), issued their own recall advice off the back of the findings.
Anyone who has suffered with bone cement complications may find the reason is to do with the product itself as opposed to failed surgery.
Breast implants cancer reporting intensifies
There has been an intensification in the need for breast implants cancer reporting. This stems from a greater focus on identifying links between implants and certain types of cancer.
We know all too well about the problems that breast implants can caused. We’re still battling for justice for women affected by the PIP Breast Implant scandal. We’ve already recovered over £1.3m in damages, and we continue to fight for UK victims here and in France.
Regulators continue to investigate links between breast implants and rare forms of cancer. Both clinicians and patients are being asked to be aware of the need to take precautions and report adverse incidents.
Latanoprost Timolol eye drops recall
A Latanoprost Timolol eye drops recall has been announced by the Medicines and Healthcare Regulatory Authority (MHRA).
The company behind the eye drops, FDC Pharma, are recalling a batch due to what has been classed as an ‘out of specification result for an unknown impurity’ that was identified during testing. Medical professionals are to stop providing the eye drops to patients, and suppliers and distributors are to cease moving the eye drops as well.
The NHS has been pushing the news throughout the Service to ensure batches affected by the Latanoprost Timolol eye drops recall are not used.
Phenytoin 90mg/5ml Oral Suspension immediate discontinuation
There has been an immediate discontinuation of unlicensed medicine Phenytoin 90mg/5ml Oral Suspension and a recall of the product.
The medication, manufactured by Rosemont Pharmaceuticals Limited, is now no longer on the shelves having been recalled and discontinued with immediate affect as a result of worrying data that suggested that the medication becomes difficult to resuspend over shelf-life.
Patients who use the Phenytoin 90mg/5ml Oral Suspension are being told to contact their doctors for more information and advice about the issues that have been identified.
Roche Diabetes Care test strip errors leads to recall
Roche Diabetes Care test strip errors has led to a recall of a number of home-use and point-of-care glucose monitoring systems.
The Roche Diabetes Care test strip errors are for the following systems: Accu-Chek Aviva; Accu-Chek Performa; and Accu-Chek Inform II.
There is a risk of a strip error message that may lead to either falsely high or falsely low blood glucose results reported.
Diabetes testing kit recall
News of a diabetes testing kit recall is said to be “urgent” amid fears of lives at risk over false readings.
The Accu-Chek Aviva and the Accu-Chek Performa are the diabetes testing kits being recalled that could lead to an overdose or an under-dose of insulin that can lead to serious health complications for users.
Advice to patients is to stop using the affected devices and return them to a pharmacy for a replacement.