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05 Mar 2018

CLH Blog - MHRA Field Safety Updates For February

CLH Blog - MHRA Field Safety Updates For February

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection EL (18) A/02 - Field Safety Alert

Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium-containing contrast media by the European Medicines Agency (EMA).

All unexpired stock of the above products marketed by Bayer plc and GE Healthcare AS is being recalled and should immediately be quarantined. This follows a safety review of the gadolinium-containing contrast media by the European Medicines Agency (EMA) which has resulted in the suspension of the above licences as of 01 February 2018.

The review concluded that small amounts of gadolinium are retained in brain tissue after the use of gadolinium contrast agents.

FSN date: 1st February 2018

Carl Zeiss Meditec AG 611P CT Lucia Intraocular Lenses  - Product Recall

Carl Zeiss Meditec Production, LLC is initiating a recall due to the detection of a potential labelling error
made during the production of Carl Zeiss Meditec AG CT LUCIA 611P, +19.5D lenses. This resulted in a
total of 57 Lenses that were potentially mislabeled with the incorrect diopter. Please find below the
product description of the affected product(s):

Carl Zeiss Lenses are intended for primary implantation in the posterior chamber in patients where a cataractous lens has been removed by cataract extraction. It is recommended that the use of the intraocular lens be initially limited to one eye.

Use of the lenses is especially appropriate in patients who cannot tolerate contact lenses, those who would not be candidates for cataract spectacles, or for patients requiring an intraocular lens for occupational or other reasons.

FSN date: 5th February 2018

OLYMPUS URF-V2 and URF-V2R URETERO-RENO VIDEOSCOPES - Device Recall 

Olympus has become aware of an issue that requires your attention. This Urgent Medical Device Recall Notice impacts the OLYMPUS URF-V2 and URF-V2R Uretero-reno videoscope(s). The URF-V2 and URF-V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.

This removal and replacement action is being taken as an Olympus decision in response to complaints regarding the breakage of the endoscope’s insertion tube bending section during surgical procedures. To date, some of these complaints are associated with tissue trauma, including one complaint of perforation, and three complaints of insertion tubes which were stuck inside the patient and had to be surgically removed. 

FSN date: 8th February 2018

Plum 360 infusion pumps - Field Safety Notice

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 

FSN date: 15th February 2018

We will be back again next month with all of the most up to date and relevant field safety alerts that have been issued.

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