Cardinal Health Kangaroo Enteral Feeding Pump Sets (ICN 1225)
Important Customer Notice Field Safety Notice
Ref: 2021/1225
ICN Number: 1225
MHRA: 2021/003/004/487/009
NHSSC: 87
Alert:
- Cardinal Health has issued a Field Safety Corrective Action Notice affecting all Kangaroo Enteral Feeding Pump Sets as listed in their Field Safety Notice event 2020 03389.
- This is due to the potential for air appearing in the enteral pump set tubing during set up.
- Air entry into the feed tubing set may potentially result in vomiting, dehydration, hypoglycaemia, abdominal pain, and abdominal distention in patients.
- The purpose of the notice is to advise users of the situation and provide guidance to help address the issue prior to the availability of the corrected product.
Products Affected:
- There are 14 NHS Supply Chain product codes affected available via our eDirect route.
- Please refer to the Field Safety Notice and Product Listing for information on the affected products.
Next Steps:
- Follow the steps described in attachment A (Air in tubing check process) to check the feed set. Retain a copy of this notice with the product.See our Downloads ▼ section.
- Communicate with all personnel that utilise these feeding sets of the potential risk of air entering feeding set tubing.
- Review, complete and sign the Acknowledgment Form as directed and email to: CordisCashel-FA-SS@cardinalhealth.com.
- Maintain awareness of this notice until all affected products have been utilised.
- Cardinal Health is implementing appropriate corrective actions to ensure this issue is corrected.
- This is not a product removal. You are not required to return any product.
- Cardinal Health advise they will continue to issue stock in scope of this Field Correction with the potential for this intermittent issue, over the coming months until all the stock is depleted.
- If you are unable to use a product affected by this issue, notify your local Cardinal Health Account Manager or contact GMB-MS-UKI-MARKETING@cardinalhealth.com who will advise next steps.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.