Product Recall Baxter Healthcare Control-A-Flo Solution Administration Set with Needle Y-Site FSB874 (ICN 2794)
Important Customer Notice Recall
NHSSC: 85
Alert:
- Baxter Healthcare has issued a Field Safety Notice recalling specific Lots of Control-A-Flo Solution Administration Sets due to customer reports of separation at the junction between the drip chamber and tubing.
- Separation of the administration set between the drip chamber and tubing may lead to delay, interruption or insufficient therapy, and exposure to air or microbial contamination.
- Depending on the type of patient access (peripheral vs. central), as well as numerous patient- and therapy-related factors, this may lead to serious or critical adverse health consequences, such as blood loss, air embolism, or bloodstream infection.
Products Affected:
- The affected product is available from NHS Supply Chains stocked route:
NPC | Product Description | Supplier Code / MPC |
Affected Lots |
FSB874 | Control-A-Flo Solution Administration
Set with Needle Y-site |
EMC5905P |
23H21V586 |
- Please note only the Lot numbers noted in the Field Safety Notice are affected.
- All NHS Supply Chain stock has been checked and affected products quarantined.
- Future orders will be fulfilled with unaffected stock.
Next Steps:
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Cease use and quarantine any affected products.
- Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return reason code 7 (supplier recall) by 7 February 2025.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.
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.