Field Safety Notice Cardinal Healthcare Chest Drainage Units and Accessories Updated Instructions for Use (ICN 3211)

NHSSC: 93

Alert:

• Cardinal Health has issued a Field Safety Notice US-MF-000006765, Event-2024-06422, to advise customers that the Instructions for Use (IFUs)) for the Cardinal Health Chest Drainage Units, (CDUs) and accessories listed have been updated to clarify the intended target patient population as adults, 18 years and older.
• This follows complaints stating that when the CDUs identified in the advisory notice are utilized on infants, the CDU may not consistently demonstrate tidaling / bubbling, which may be used by clinicians to determine if the unit is functional.
• The lack of consistent tidaling or bubbling may affect the clinician’s assessment of device functionality and may lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
• For clarity, when used in non-adult patient populations the CDUs are capable of providing a seal; however, the CDU may not consistently demonstrate tidaling / bubbling due to the size of the collection chambers, even when a seal is present.
• Cardinal Health advise the CDUs have been under the same design since their release and continue to perform as intended.

Products Affected:

• 12 products are affected.
• Eight of the products affected are available from NHS Supply Chain, please see attached product listing for details.
• Please note this is not a product withdrawal.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Continue utilizing the CDUs on adult patients (not paediatric patients or infants).
• Post a copy of the Field Safety Notice in your storeroom and clinical areas.
• Complete the attached Customer Acknowledgement Template and return to Terry Harrison, Cardinal Health’s Sales Representative by email: terry.harrison@cardinalhealth.com

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