GOV.UK
36 alerts about Haematology and oncology
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BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology
Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.
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Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)
Caution in Use: Distribute to Pharmacy and Clinic Level.
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All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
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Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall
Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)
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Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit.
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Field Safety Notice - 26 February – 02 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
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Aquilon series of nebulisers – CE mark withdrawn and supply ceased
Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
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Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU
Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed
Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)
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Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate)
Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL (18) A/03)
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Plum 360 infusion pumps – user actions required to prevent risk of interrupted infusion or delay to treatment
Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents
Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.
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All Philips HeartStart MRx monitors/defibrillators – significant delay in the supply of batteries
The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
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Syringe pumps – required user actions in the event of PL3 alarm to prevent risk of interrupted infusion
BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).
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Class 4 Medicines Defect Information: Co-Amoxiclav 1000mg/200mg Powder for Solution (EL (17) A-14)
Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
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Class 4 Medicines Defect Information: BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes
Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Field Safety Notice - 27 November to 1 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
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Field Safety Notice - 23 to 27 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Class 4 medicines defect information: Kyowa Kirin Bleo-Kyowa® Powder for Solution for Injection 15,000 IU
Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban)
Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected.
Manufactured by Philips Healthcare: Error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ECG trace, distorting the ST segment, leading to risk of misinterpretation or misdiagnosis. (MDA/2017/031)
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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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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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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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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 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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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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BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy
Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.
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Steel cannula infusion sets - risk of needle breaking in use
(Unomedical a/s) May cause leakage of medication and require surgical intervention to remove the needle (MDA/2015/027)
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Metal-on-metal (MoM) hip replacements - guidance on implantation and patient management
[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
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All medical devices - ensure system is in place to distribute field safety notices (FSNs)
(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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Breast implants - report cases of anaplastic large cell lymphoma (ALCL)
(All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)
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Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn
(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion
(Hospira) Due to pump faults. (MDA/2013/016)
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Intravenous (IV) extension sets with multiple ports - risk of backtracking
(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)