Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2019 – 30.06.2019

Опубліковано 01.07.2019 о 15:47

Великобританія

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

 

List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 June 2019

Alert type: Field safety notice

 Issued: 4 July 2019

Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.

Alert type: Medical device alert Medical specialism: Anaesthetics and 6 others Issued: 2 July 2019

Medicines have been taken out of the regulated medicines’ supply chain during distribution.

Alert type: Drug alert Medical specialism:  Pharmacy Issued:  27 June 2019

Manufactured by B.

Alert type: Medical device alert Medical specialism: Renal medicine  Issued:

 26 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 07 to 21 June 2019

Alert type:  Field safety notice  Issued:  24 June 2019

Pfizer UK Limited is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

Alert type:  Drug alert: company-led  Issued:  24 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 June 2019

Alert type:  Field safety notice  Issued:  17 June 2019

M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.

Alert type:  Drug alert  Medical specialism:  Pharmacy  Issued: 13 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 June 2019

Alert type:  Field safety notice  Issued: 10 June 2019

Recommendations following publicised concerns over an increase in patient mortality from two years after treatment.

Alert type: Medical device alert  Medical specialism:  General surgery and 2 others

 Issued:4 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 May 2019

Alert type:

 Field safety notice  Issued:  3 June 2019

Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.

Alert type:  Drug alert  Issued:

 3 June 2019

Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode.Alert type:  Medical device alert  Medical specialism:

 Anaesthetics and 1 others

 Issued: 30 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 20 to 25 May 2019

Alert type:  Field safety notice  Issued:  29 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 May 2019

Alert type:  Field safety notice  Issued:

 20 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 May 2019.

Alert type:  Field safety notice  Issued: 13 May 2019

Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle.

Alert type:  Drug alert  Issued:  13 May 2019

Macopharma is recalling certain batches of intravenous infusion bags as a precaution.

Alert type:  Drug alert: company-led  Issued:  7 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 29 April to 3 May 2019.

Alert type:  Feld safety notice  Issued:7 May 2019

Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. Update includes further advice on how to detect features of Nellix endograft failures.

Alert type: Medical device alert  Medical specialism:

 Radiology and 1 others  Issued:  1 May 2019

Manufactured by Etac and supplied in UK by R82 UK Ltd – if the hooks connecting the spreader bar to the hoist break during use, the patient could fall.

Alert type:   Medical device alert  

Medical specialism:  Care home staff and 1 others

 Issued:

 1 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 23 to 26 April 2019.

Alert type: Field safety notice

 Issued: 29 April 2019

Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg.

Alert type: Drug alert Issued:

 26 April 2018

Ethicon Curved Intraluminal Staplers – risk of failure of staple lines (MDA/2019/019)

Manufactured by Ethicon – use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding.

Alert type: Medical device alert

 Medical specialism: General surgery and 2 others Issued:

25 April 2019

Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules.

Alert type: Drug alert Issued:

 24 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 April 2019

Alert type: Field safety notice Issued:

 23 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 2019

Alert type: Field safety notice Medical specialism: Orthopaedics and 1 others

 Issued:

15 April 2019

Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, legal status ‘P’.

Alert type: Drug alert Issued: 9 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019

Alert type: Field safety notice Medical specialism: Anaesthetics and 1 others Issued:

 4 April 2019

B.Alert type:

 Drug alert Medical specialism: Critical care and 1 others Issued:

 8 April 2019

Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from a batch of Zoledronic acid 5mg solution for infusion contain a Patient Information Leaflet for Temozolomide 180mg Capsules.Alert type: Drug alert

 Issued: 4 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 March.

Alert type: Field safety notice Issued:

 1 April 2019

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