03 Oct 2017

CLH Blog - MHRA Field Safety Updates For September

CLH Blog - MHRA Field Safety Updates For September

Once again, we’ve research the many field safety alerts that have been filed over the last month and have put together a roundup of all of the most relevant MHRA updates and recalls. These focus on updates for health care products and equipment that are relevant to UK care homes and other health 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’s important to immediately act on it.

Hyphen Biomed: Biofen Arixtra Control Plasma Ref 224001 - LOT F1600528

If the calibration curve is validated with a C1 control between 0.3 and 0.35, dosage values in the lower zone may be underestimated. The potential risk is not significant and does not affect patient clinical setting.

FSN date: 6th September 2017

Zimmer Biomet: ExploR 7x26mm Implantable Stem with Screw - urgent medical device alert

Zimmer Biomet is conducting a single lot medical device field action for the ExploR 7x26mm Implantable Stem with Screw due to two complaints reporting that the Modular Radial HD lock screw was not included in the package for the stem.

FSN date: 11th September 2017

Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery

Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated. Action to be taken: identify affected ventilators. There is an external battery connected to each unit for use when mobile, this is a backup power source that can be used at any time. Once available, the warning sticker should be placed on affected ventilators.

FSN date: 12th September 2017

All Accu-Chek® Insight insulin pumps – risk of alarm failure

Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.

FSN date: 20th September 2017

Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban)

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. It is advised that you quarantine any remaining stock from batch BXHHDR1 and return it to the original supplier.

FSN date: 29th September 2017

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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