Guidance

Safety Bulletin 7: Safety concern over imported liferafts containing medical kits

Alerts industry to specific issues. Normally time sensitive and action may be required.

• From: Maritime and Coastguard Agency
• Published: 27 April 2016

This publication was withdrawn on 28 August 2024

This page has been withdrawn as it is out of date. For more information on category C medical kits see MGN 524 (M+F) Amendment 1 – Life-saving appliances – category C medical kits.

Documents

Safety Bulletin 7: Safety concern over imported liferafts containing medical kits

Ref: SBI007

HTML

Details

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Maritime & Coastguard Agency (MCA) are jointly issuing a warning that imported liferafts may contain unlicensed imported medicines, as well as medical devices that do not carry a CE Mark.

Suppliers of inflatable liferafts in the UK are asked to check the origin of their liferafts immediately to establish if any of the contents of the medical kit inside is compliant with UK medicines legislation.

This bulletin is applicable to suppliers of liferafts intended for commercial and pleasure vessels and requests that suppliers of imported rafts open at least one raft from each non-UK supplier to ensure it does not contain non-compliant medicines.

Published 27 April 2016