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03 Jan 2019

CLH Blog - MHRA Field Safety Updates For December 2018

CLH Blog - MHRA Field Safety Updates For December 2018

Well here it is, before we move on to a new year, the last field safety alerts that have been filed during December 2018 and we have as usual 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.


Firstly, an update on EU Exit refering back to an August 2018 notification to suppliers of medical devices and clinical consumables supply in a March 2019 'no deal' scenario:

Read the letter from the Rt Hon Matt Hancock MP, Secretary of State for Health and Social Care here.


Field Safety Notice: 1811/43093/00 Vygon UK Dualstop Stoppers

Product Area: Sterile Intervention Equipment

Vygon UK has issued a Field Safety Notice following the discovery of a manufacturing defect in a range of lot numbers of Dualstop stoppers.

Impact: The defect may result in the Dualstoppers leaking during use.


Delisting: Ecolab Ltd have notified a discontinuation with its Dispensers and Accessories Hook Attachment Bracket


Field Safety Notice: Halyard Health Maxter Entral Side Load Clamp Tubes EMEA 2018 014

Product area: Ward Based Consumables

A Field Safety Notice has been issued from Halyard Health regarding its Maxter Entral Side Load Clamp Tubes.

Halyard Health UK Limited has issued a Field Safety Notice to alert users to a potential choking hazard associated with an accessory Maxter Entral side load clamp for tubes >14fr (small), they distribute.

Impact: Maxter Catheters received one unconfirmed report of a young patient playing with and eventually placing the product in their mouth, causing them to begin to choke. A healthcare provider removed the clamp from their mouth and the patient recovered. Although the likelihood of harm is improbable, this notice is intended to inform all users of the potential choking hazard.

Those in receipt of the product have been notified to please complete and return the Customer Acknowledgement Form to Veronique.paulin@hyh.com within five days of receipt of the notice.


Recall: JD Marketing Brushing for Life packs have been recalled

Product area: Diagnostic Pathology and Therapy Technologies

Further to ICN 402 from September 2018 it was advised that Brushing for Life packs had been suspended pending the investigation of a product complaint.
A decision has now been taken to withdraw all JD Marketing Brushing for Life packs. This withdrawal affects all Lot numbers for all Brushing for Life packs.

Impact: The sucker pads at the base of the toothbrush handle could be easily separated from the body of the toothbrush and therefore potentially become a choking hazard.


We’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroup to let us know and don’t forget to use '#CommittedToCare' in your posts.

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