Field Safety Notice Pasante Healthcare Karex Ultrasound Probe Cover (ICN 3128)

NHSSC: 79

Alert:

• Karex, UK Distributor Pasante, has issued a Field Safety Notice for their Ultrasound Probe Cover following discovery that the QR Code expiry date differs from the printed date on the packaging for a single lot number.
• The expiry date printed on the packaging is 28-04-30 whereas the incorrect expiry date encoded in the QR code is 08-04-30.
• The incorrect expiry date encoded in the QR code may cause misinterpretation of the product’s shelf life.
• Karex advise they consider the risk to users as negligible. The discrepancy is limited to the expiry date encoded in the QR code, the printed expiry date on the packaging is correct.
• This issue does not affect the product’s quality, safety or performance and there is no impact on the effectiveness or usability of the product when used as intended.

Products Affected:

• The product affected is available from NHS Supply Chain’s stocked route:

• Please note only the lot number quoted in the Field Safety Notice and above is affected.
• This is not a product withdrawal; the affected lot number is still in the supply chain.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Inform all affected customers of the discrepancy between the expiry date printed on the packaging (28-04-30) and the expiry date encoded in the QR code (08-04-30). Advise them to refer to the printed expiry date as correct.

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

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.