Alerts, recalls and safety information: drugs and medical devices

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: 30 October 2017

Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level

• Medical specialism: Anaesthetics and 21 others
• Issued: 13 November 2017

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.

• Medical specialism: Anaesthetics and 21 others
• Issued: 29 September 2017

(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)

• Medical specialism: Anaesthetics and 21 others
• Issued: 4 September 2017

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.

• Medical specialism: Anaesthetics and 21 others
• Issued: 31 July 2017

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.

• Medical specialism: Anaesthetics and 21 others
• Issued: 13 July 2017

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…

• Medical specialism: Anaesthetics and 21 others
• Issued: 30 June 2017

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: Device safety information
• Medical specialism: Anaesthetics and 18 others
• Issued: 24 May 2017

Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 18 May 2017

(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 4 others
• Issued: 11 June 2015

(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 26 September 2014

(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)

• Alert type: Device safety information
• Medical specialism: Critical care and 5 others
• Issued: 27 March 2013

(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 9 others
• Issued: 28 June 2012

(All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD. (MDA/2009/080)

• Alert type: Device safety information
• Medical specialism: Infection prevention
• Issued: 9 December 2009