Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2021 – 30.06.2021

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

https://www.gov.uk/drug-device-alerts

https://www.gov.uk/drug-device-alerts?page=2

 

• Field Safety Notices: 13 to 17 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021

• Alert type: Field safety notice

 

• Issued: 20 September 2021

• Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.

• Medical specialism: Dispensing GP practices and 1 others

 

• Issued: 15 September 2021

• Field Safety Notices: 6 to 10 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021

• Alert type: Field safety notice

 

• Issued: 13 September 2021

• Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets (EL (21)A/21)

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.

• Medical specialism: Dispensing GP practices and 1 others

 

• Issued: 9 September 2021

• Field Safety Notices: 30 August to 3 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 2021.

• Alert type: Field safety notice

 

• Issued: 6 September 2021

• Medical device alerts archived in September 2021

Following our latest review of medical device alerts, we have archived the ones listed below.

• Alert type: Device safety information

 

• Issued: 2 September 2021

• Field Safety Notices: 23 to 27 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August

• Alert type: Field safety notice

 

• Issued: 31 August 2021

• Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20

Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.

• Medical specialism: Anaesthetics and 21 others

 

• Issued: 25 August 2021

• Field Safety Notices: 16 to 20 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 August

• Alert type: Field safety notice

 

• Issued: 23 August 2021

• Field Safety Notices: 9 to 13 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 August

• Alert type: Field safety notice

 

• Issued: 16 August 2021

• Field Safety Notices: 2 to 6 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August

• Alert type: Field safety notice

 

• Issued: 9 August 2021

• Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19

Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

• Medical specialism: Anaesthetics and 21 others

 

• Issued: 5 August 2021

• Field Safety Notices: 26th to 30th July 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 26 to 30 July 2021

• Alert type: Field safety notice

 

• Issued: 2 August 2021

• Field Safety Notices: 19 to 23 July 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 19 to 23 July 2021.

• Alert type: Field safety notice

 

• Issued: 26 July 2021

• Field Safety Notices: 11 to 16 July 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 16 July 2021.

• Alert type: Field safety notice

 

• Issued: 19 July 2021

• Class 4 Medicines Defect Information, Amoxicillin 500 mg/ 5 ml Powder for oral suspension, (PL 25298/0248), EL (21)A/18

Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoa…

• Medical specialism: Pharmacy

 

• Issued: 19 July 2021

• Field Safety Notices: 5 to 9 July 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 5 to 9 July 2021.

• Alert type: Field safety notice

 

• Issued: 12 July 2021

• Class 4 Medicines Defect Information, Sevredol 10 mg and 20mg tablets, (PL 16950/0063, PL 16950/0064), EL (21)A/17

Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.

• Medical specialism: Pharmacy

 

• Issued: 12 July 2021

• Class 4 Medicines Defect Information, Tetralysal 300mg Hard Capsules, (PL 10590/0019), EL (21)A/16

Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.

• Medical specialism: Pharmacy

 

• Issued: 6 July 2021

• Field Safety Notices: 28 June to 2 July 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 28 June to 2 July 2021.

• Alert type: Field safety notice

 

• Issued: 5 July 2020

• Company led medicines recall: Morphine Syringe 50mg/50ml (unlicensed medicine) and Magnesium Sulphate 8mmol/20ml infusion (unlicensed medicine)

Nova Laboratories Limited (MS 13581) is recalling specific batches of the impacted products due to a potential risk of contamination.

• Medical specialism: Pharmacy

 

• Issued: 1 July 2021

• Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15

Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.

• Medical specialism: Anaesthetics and 21 others

 

• Issued: 1 July 2021

• Medical devices sterilised by Steril Milano – potential for incomplete sterilisation (DSI/2021/008)

Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks.

• Alert type: Device safety information

 

• Issued: 29 June 2021

• Field Safety Notices: 21 to 25 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 21 to 25 June 2021.

• Alert type: Field safety notice

 

• Issued: 28 June 2021

• National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA)

Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.

• Alert type: National patient safety alert

 

• Medical specialism: Anaesthetics and 5 others

 

• Issued: 23 June 2021

• Field Safety Notices: 14 to 18 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 14 to 18 June 2021.

• Alert type: Field safety notice

 

• Issued: 21 June 2021

• Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products, EL (21)A/14

Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.

• Medical specialism: Anaesthetics and 21 others

 

• Issued: 17 June 2021

• National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRA

Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential…

• Alert type: National patient safety alert

 

• Medical specialism: Anaesthetics and 21 others

 

• Issued: 16 June 2021

• Field Safety Notices: 7 to 11 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 June 2021.

• Alert type: Field safety notice

 

• Issued: 14 June 2021

• Company led medicines recall: Noidecs T20/C4 (THC 20%; CBD <4%) Indica Cannabis Flower (unlicensed medicine) and Noidecs T20/C4 (THC 20%; CBD <4%) Sativa Cannabis Flower (unlicensed medicine)

The importer and distributor of the above products (Eaststone Limited) has informed us of reports that two affected batches may be contaminated with mould.

• Medical specialism: Pharmacy

 

• Issued: 9 June 2021

• Field Safety Notices: 31 May to 4 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 31 May to 4 June 2021.

• Alert type: Field safety notice

 

• Issued: 7 June 2021

• Field Safety Notices: 24 to 28 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 24 to 28 May 2021.

• Alert type: Field safety notice

 

• Issued: 1 June 2021

• Field Safety Notices: 17 to 21 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 17 to 21 May 2021.

• Alert type: Field safety notice

 

• Issued: 24 May 2021

• Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13

Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.

• Medical specialism: Pharmacy

 

• Issued: 20 May 2021

• Recall of BD Venflon Pro safety and Venflon Pro IV cannula (DSI/2021/006R)

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

• Alert type: Device safety information

 

• Medical specialism: Anaesthetics and 13 others

 

• Issued: 4 May 2021

• Company led medicines recall: LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005)

Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.

• Medical specialism: Haematology and oncology and 1 others

 

• Issued: 19 May 2021

• Field Safety Notices: 10 to 14 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 10 to 14 May 2021

• Alert type: Field safety notice

 

• Issued: 17 May 2021

• Class 2 Medicines Recall: AstraZeneca UK Limited, Bricanyl Injection, 0.5 mg/ml solution for injection or infusion (PL 17901/0112), EL (21)A/12

AstraZeneca UK Limited is recalling the above batch of Bricanyl 0.5mg/ml solution for injection or infusion as a precautionary measure due to out of specification results for a routinely tested known impurity during sta…

• Medical specialism: Pharmacy

 

• Issued: 17 May 2021

• Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (DSI/2021/007)

Recommendations for clinicians including not implanting these devices

• Alert type: Device safety information

 

• Medical specialism: Orthopaedics

 

• Issued: 10 May 2021

• Field Safety Notices: 3 to 7 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 3 to 7 May 2021

• Alert type: Field safety notice

 

• Issued: 10 May 2021

• Field Safety Notices: 26 to 30 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 April 2021

• Alert type: Field safety notice

 

• Issued: 4 May 2021

• Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192), EL (21)A/11

Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to …

• Medical specialism: Pharmacy

 

• Issued: 4 May 2021

• Field Safety Notices: 19 to 23 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 2021

• Alert type: Field safety notice

 

• Issued: 26 April 2021

• Class 2 Medicines Recall: Ennogen Pharma Limited, Trimethoprim 200mg Tablets (PL 40147/0083), EL (21)A/10

Ennogen Pharma Limited are recalling an affected batch of Trimethoprim 200mg Tablets as a precautionary measure due to the observation of a foreign tablet, which is identified as Trimethoprim 100mg Tablet.

• Medical specialism: Pharmacy

 

• Issued: 22 April 2021

• Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue (DSI/2021/005)

Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.

• Alert type: Device safety information

 

• Issued: 20 April 2021

• Field Safety Notices: 12 to 16 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021

• Alert type: Field safety notice

 

• Issued: 19 April 2021

• Field Safety Notices – 05 April to 09 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021

• Alert type: Field safety notice

 

• Issued: 19 April 2021

• Dexcom G6 Sensor: untested barrier methods to reduce skin reactions (DSI/2021/004)

Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.

• Alert type: Device safety information

 

• Issued: 6 April 2021

• Field Safety Notices – 29 March to 02 April 2021

List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.

• Alert type: Field safety notice

 

• Issued: 6 April 2021

• Field Safety Notices – 22 to 26 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 2021.

• Alert type: Field safety notice