Field Safety Notice Medicina ENfit Nasogastric Feeding Tubes Amended Instructions For Use Multiple Products (ICN 1438)

Recall Ref: 56

Alert:        

• The HMC and Medicina Nasogastric and Nasojejunal range of tubes are used by healthcare professionals across a wide variety of patients from neonates to adults, both in hospital and at home, to feed, flush, deliver medicines and to aspirate stomach content to confirm correct placement.
• HMC and Medicina nasogastric and Nasojejunal feeding tubes are not intended and should never be used for high volume decompression in emergency situations or decompression for high volume or high viscous fluid.
• This is due to the inner diameter of ENFit connector (as per ISO 80369-3 standard), which is used on Nasogastric and Nasojejunal feeding tubes with the specific intended use of enteral formula delivery, and not for high volume decompression in emergency situations or decompression for high volume or high viscous fluid.
• Where quick decompression of high amounts of stomach content and/or the connection to a suction are required, large bore decompression tubes with a suitable connector (e.g., Funnel connector) should be considered.

Products Affected:

• A number of these products are available from NHS Supply Chain please refer to the attached product listing.

Next Steps:

• After a review and update of their Risk Management processes, both Medicina and HMC have updated their instructions for use to include the below explicit contraindication.

This device should not be used for high volume decompression in emergency situations, those at high risk of aspiration and/ or for decompression for high volume or high viscous fluid.

• Read the Field Safety Notice and share with all users of these devices throughout your organisation.
• Complete and return the Acknowledgment Form, page 8 of the Field Safety Notice, by email to Quality.administrator@medicina.co.uk as soon as possible.
• If you have any questions please direct these to  Shaista Patel, QA/RA Administrator, Medicina either by telephone : 01204 695050 or E Mail : quality.administrator@medicina.co.uk

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.