GOV.UK
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Field Safety Notice - 18 to 22 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 September 2017.
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All Accu-Chek® Insight insulin pumps – risk of alarm failure
Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
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Field Safety Notice - 11 to 15 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 September 2017.
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Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated.
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Field Safety Notice - 04 to 08 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 2017
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Field Safety Notice - 29 August to 1 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 2017
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Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level
(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
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Replacement bileaflet mechanical heart valves – risk of inverted implantation
Specific manufacturers – measures to prevent inverted valve implantation resulting from incorrect mounting of the valve on its valve holder.
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Field Safety Notice - 14 to 18 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 August 2017
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Field Safety Notice - 21 to 25 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 August 2017
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Intra-aortic balloon pump (IABP): CS100, CS100i and CS300 – risk of haemodynamic instability to patients with critical conditions due to a delay in or sudden interruption of therapy
Manufactured by Datascope Corp – an electrical fault caused by a solenoid valve could mean the device fails to start or deliver therapy to patients (MDA/2017/027)
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Overhead hoist: Freeway Easy Fit system with a swivelling trolley – risk of fixing pin moving or splaying
Manufactured by Prism – splayed or misplaced pins may lead to the hoop detaching and dropping the sling.
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Nail intramedullary fixation system: Trauma guide wires 70cm – risk of infection
Manufactured by Zimmer Biomet – Recall due to risk of infection if the wire breaks through the packaging (MDA/2017/025)
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Insulin pens: NovoPen Echo and NovoPen 5 (certain batches) – risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals
Manufactured by Novo Nordisk - recall and replacement of specific batches of cartridge holder (MDA/2017/024)
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Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration
Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023)
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DePuy Synthes Impactor for PFNA (Proximal Femoral Nail Anti-rotation) Blade: risk of infection
Manufactured by Synthes GmbH – Recall due to risk of infection from cracked weld of the handle.
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VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards – potential false resistance for antibiotics on the AST panel, leading to false negative ESBL test or false positive urea (URE) reaction on ID cards
Manufactured by BioMérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.
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Field Safety Notice - 7 to 11 August
Summary List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 August 2017
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Field Safety Notice - 31 July to 4 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 31 July to 4 August 2017
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Field Safety Notice - 24 to 28 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 2017
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Class 3 Medicines Recall: Specific batches of Torrent Dutor (Duloxetine) Gastro-resistant Capsules
Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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Field Safety Notice - 17 to 21 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 July 2017
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Field Safety Notice - 3 to 7 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017
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Field Safety Notice - 10 to 14 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017
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Sodium Chloride Infusion 0.9% w/v 1000 mL bags
Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Haemofiltration machine: all Prismaflex systems installed with software version 6.10 – risk of under-infusion of anticoagulant
Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
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Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask
Manufactured by ConvaTec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (MDA/2017/019)
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Field Safety Notice - 26 to 30 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 June 2017
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Parallel Imported One-Alpha Drops x 10 ml - Pharmacy and wholesaler level recall of two batches
Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the pack.
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All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
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Field Safety Notice - 19 to 23 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 June 2017
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BVM (Bag-Valve-Mask) manual resuscitation systems – risk of delay to emergency treatment
Manufactured by Intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
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Field Safety Notice - 12 to 16 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 June 2017
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Field Safety Notice - 5 to 9 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 June 2017
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DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System.
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Solus Flexible Wire Reinforced Laryngeal Mask Airway – risk of hypoxia due to partial or total occlusion of the airway tube after inflating the cuff
Manufactured by Intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
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Field Safety Notice - 29 may to 2 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 May to 2 June 2017
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Field Safety Notices - 22 - 26 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 2017.
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All HeartStart MRx defibrillators – possible failure to deliver a shock, cardioversion, pacing or monitoring
Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Field Safety Notice - 15 to 19 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 May - 19 May 2017.
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Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops
FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
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All LIFEPAK 1000 automatic external defibrillators (AEDs) - risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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V60 ventilator – potential for unexpected shutdown
Manufactured by Philips Respironics – faulty software can cause false alarms for stalled blower motor, leading to unexpected shutdown
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Field Safety Notice - 8 to 12 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 2017.
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Field Safety Notice - 1 May to 5 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 1 May - 5 May 2017
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Biological replacement pericardial aortic heart valve: Mitroflow LX (sizes 19mm and 21mm) – risk of early structural valve deterioration
Manufactured by LivaNova – increased risk of earlier than anticipated structural valve deterioration (SVD) particularly with the smaller sizes.
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All Accu-Chek® Insight insulin pumps – updated information for battery management
Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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Field Safety Notice - 24 April to 28 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017
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Recall of Human Albumin Biotest CLDA (17)A/02
Biotest UK Ltd is recalling the listed batches due to low level contamination which occurred during manufacture
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Field Safety Notice - 18 April to 21 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18-21 April 2017
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