Field Safety Notice Cardinal Health Kangaroo Enteral Feeding Sets (ICN 2350)
Important Customer Notice Update
- Cardinal Health has issued an update to the Field Safety Notice for their Kangaroo Enteral Feeding Pump Sets (air in line).
- Cardinal Health have completed their investigation and implemented appropriate corrective actions to ensure manufacturing related issues are addressed.
- Please report any product issues you encounter while using the products listed to NHS Supply Chain.
- If you have any questions regarding this Field Safety Notice, please contact your local Cardinal Health Sales Representative or local sales office, or email: UKQRA@cardinalhealth.com
- Cardinal Health has issued a Field Safety Notice for six devices in the Kangaroo Enteral Feed Pump Set range due to the potential for air appearing in the enteral feed pump set.
- Air entry into the feed set tubing may potentially result in the following health consequences to the patient: vomiting, dehydration, hypoglycaemia, weight change, electrolyte imbalance, abdominal pain, and abdominal distention,
- Four of the affected products are available from NHS Supply Chain:
|Supplier Code / MPC
|Giving Set ENFit ENplus Spike Set
|Giving Set ENfit Dual ENplus Spike Set
|Giving Set ENfit ENplus 3 in 1 Set
|Giving Set ENfit 1000ml Set
- Please note only products manufactured from April 2022 with Lot numbers 22D to July 2023 to Lot number 23G are affected, as listed in the Field Safety Notice.
- Cardinal Healthcare advise they are implementing the appropriate corrective actions to ensure that the issue is corrected.
- Read and follow the full instructions in the Field Safety Notice including the steps described in Attachment A, to assess and monitor for entry of air into the feed set. Retain a copy of the notice with the product.
- Share the Field Safety Corrective Action Notice and appendix with all users of the affected products.
- Cardinal Health confirm this is not a product removal, no product return is required.
- If you have any questions regarding this Field Safety Notice please contact your local Cardinal Health Sales Representative, or local sales office, or email: UKQRA@cardinalhealth.com
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
Please be aware that in the event of a Field Safety Notice/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.