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(Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)
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(OPD Laboratories Limited) Recall as some packs have incorrectly-labelled blister strips – class 2 action within 48 hours. (EL (13)A/01)
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(Merck Sharp & Dohme Limited trading as Organon Laboratories Limited) Technical portion of leaflet aimed at the healthcare professional omitted. (EL (12)A/35)
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(Various manufacturers) Check labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy. (MDA/2012/075)
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(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)
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(Pfizer Limited) Clarification of confusion resulting from amended labels and patient information leaflet – class 4 caution in use. (EL (12)A/31)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(Special Products Ltd) Packs containing the new syringe to be distributed from September 2012 – class 4 caution in use - class 4 caution in use. (EL (12)A/26)
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GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product. This is due to incorrect dosing instructions on the patient information leaflet advising patients to take half the recommended dose - c…
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(Actavis UK Ltd) Use of incorrect blister foil which fails to meet the specification for child resistancen – class 2 action within 48 hours. (EL (12)A/24)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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[Archived] (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)
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(Lincoln Medical Limited) Potential problem could result in a failure to deliver any adrenaline at all in an emergency situation – class 2 action within 48 hours. (EL (12)A/20)
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(Teva UK and Numark liveries) Remaining stock should be returned to wholesaler for credit – class 3 action within 5 days. (EL (12)A/13)
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(Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)
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(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)
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(Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)
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(Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (MDA/2012/011)
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(Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)
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(Merck Serono) Contraindicated for patients with allergies to soya oil - class 4 caution in use. (EL (14)A/15)
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(MIBE GMBH) Contraindicated for patients with allergies to peanut oil - calls 5 caution in use. (EL (12)A/03)
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(Lundbeck Limited) Reports of cracked ampoules and concerns about guaranteeing sterility – class 2 actions within 48 hours (EL (11)A/33)
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(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
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(Eli Lilly) Recall following clinical trial findings showing lack of efficacy and risk/benefit concerns – class 1 action now. (EL (14)A/15)
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(Reckitt Benckiser (UK) Ltd) Recall of all unexpired stock of Nurofen Plus tablets in any pack size – class 1 action now. (EL(11)A/21)
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(Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)
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(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/…
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)
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(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
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(All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)
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(GlaxoSmithKline (GSK)) Recall of all undispensed UK packs purchased through approved suppliers Alliance Healthcare and AAH Pharmaceuticals - class 3 action within 5 days. (EL(10)A/22)
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(Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out. (MDA/2010/078)
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(All brands) risk of back-tracking when an IV line has multiple access ports, which can lead to under-infusion or bolus delivery of IV drugs. (MDA/2010/073)
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(Merz Pharmaceuticals GmbH) manufacturer has received reports of adverse reactions to the filler. (MDA/2010/064)
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(All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002. (MDA/2010/054)
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(Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (MDA/2010/039)
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(All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier. (MDA/2010/036)
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(Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (MDA/2010/025)
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(All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis. (MDA/2010/020)
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(intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase. (MDA/2010/008)
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(All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).
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(All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)
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(All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD. (MDA/2009/080)
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(Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines. (MDA/2009/076)
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(All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)
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(Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)
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(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)
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(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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(All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)