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List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 3 others
- Issued:
-
Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Haematology and oncology
- Issued:
-
Manufactured by Philips – Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
- Alert type:
- Medical device alert
- Medical specialism:
- Cosmetic surgery and 4 others
- Issued:
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IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by BD (formerly Carefusion) – specific batches manufactured from July 2015 to Sept 2016 inclusive. Risk of leakage or disconnection of tubing caused by inadequately sealed connections.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 14 others
- Issued:
-
Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 17 others
- Issued:
-
FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
Caution in Use: Distribute to Pharmacy and Clinic Level.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 16 others
- Issued:
-
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)
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Haematology and oncology and 1 others
- Issued:
-
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit.
- Alert type:
- Drug alert
- Medical specialism:
- Haematology and oncology and 1 others
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 15 others
- Issued:
-
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
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).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 2 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
- Alert type:
- Drug alert
- Medical specialism:
- Cardiology and 10 others
- Issued:
-
Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 15 others
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 16 others
- Issued:
-
Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 12 others
- Issued:
-
(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 7 others
- Issued:
-
(Unomedical a/s) May cause leakage of medication and require surgical intervention to remove the needle (MDA/2015/027)
- Alert type:
- Medical device alert
- Medical specialism:
- General practice and 2 others
- Issued:
-
[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
- Alert type:
- Medical device alert
- Medical specialism:
- General practice and 7 others
- Issued:
-
(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
(All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)
- Alert type:
- Medical device alert
- Medical specialism:
- Cosmetic surgery and 3 others
- Issued:
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