Field Safety Notice SteriFeed Colostrum Collection Device Risk Of Choking (ICN 2303)

Alert:

• The Medicines and Healthcare Products Regulatory Agency has issued a Field Safety Notice and Device Safety Information regarding the correct use of the SteriFeed Colostrum Collection Device following a number of reported incidents.
• The supplier Medicare Colgate Ltd (SteriFeed) has also issued the full Field Safety Notice.
• The SteriFeed Colostrum Collection Device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in the baby’s throat.

This device is not designed for feeding.

• The Medicines and Healthcare Products Regulatory Agency understand that it has also been used for feeding colostrum to babies and is aware of six incidents in which the push cap became lodged in the back of the baby’s mouth when it was not removed from the top end of the syringe before being inserted into the baby’s mouth for feeding. There were no fatalities however, one infant required emergency surgery.

Products Affected:

•  This product is available from NHS Supply Chain:

• Please note this is not a product recall.
• The Medicines and Healthcare Products Regulatory Agency has advised the manufacturer is undertaking a design change to minimise the choking hazard associated with the cap. Work is underway on this change and it will take approximately 6 months.
• See our Downloads ▼ section to access the Field Safety Noticed from the supplier and the Medicines and Healthcare Products Regulatory Agency Communication.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice:
  • SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010

• Share with all users of the affected products.
• Do not use the device for directly feeding the colostrum to babies. The cap must always be removed before use.
• Healthcare professional advice should be sought for guidance on feeding the collected colostrum to the baby.

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

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.