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Device safety informationMHRA

SteriFeed Colostrum Collection device safety warning over a safety concern

Device safety concern

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.

What to do now

The MHRA has published safety information about SteriFeed Colostrum Collection device and risk of choking.

  1. Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
  2. Check the model, lot or serial number against the details on this page.
  3. Any incident involving the device can be reported through the Yellow Card scheme.

Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.

Replacements and support

Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.

Do not throw away a device you rely on until a replacement has been arranged.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (DSI/2023/010). Quoted as issued.

Summary

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.

The risk

Devices Details Device Name: SteriFeed Colostrum Collector Product code: 11201

Advice for healthcare professionals

Actions for healthcare professionals

Remove the cap before using the device.

When instructing parents on using the device, remind them to always remove the cap from the tip of the syringe prior to use.

Advise parents on how to feed the collected colostrum to the baby.

There are specific reporting arrangements for healthcare professionals to follow in each of region. Healthcare professionals should report incidents:

in England and Wales to the Yellow Card scheme or via the Yellow Card app

in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system

in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system

Actions for users

Remove the cap from the top end of the syringe before using the device.

Seek advice from a healthcare professional for guidance on how to feed the harvested colostrum to your baby.

Actions for manufacturers

Open the MHRA notice

Questions

Why has SteriFeed Colostrum Collection device and risk of choking been recalled?

The MHRA has published safety information about SteriFeed Colostrum Collection device and risk of choking. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.

How do I know if my product is affected?

The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.

What should I do now?

Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.

Who replaces the device?

Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.

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