Field Safety Notice Baxter Healthcare Welch Allyn Non-Automated Blood Pressure Gauges Correct Storage Temperature (ICN 2948)

• Please see the updated product listing now showing 11 devices available via NHS Supply Chain affected by Field Safety Notice FA 2024 071.

NHSSC: 13

Alert:

• Baxter Healthcare has issued a Field Safety Notice (reference FA 2024 071) to inform customers of the correct storage temperature for the Welch Allyn Non-Automated Blood Pressure Gauges.
• Storage at temperatures of or exceeding 40C/104F may result in the gauges not meeting leak and accuracy specifications.
• Baxter recommend storing the devices at a temperature not exceeding the operating temperature of 40C/104F.
• Baxter advise there is a remote risk that the blood pressure gauges exposed to high temperature storage could lead to inaccurate measurement of blood pressure or the inability to inflate the blood pressure cuff.

Products Affected:

• Eight of the products affected are available from NHS Supply Chain.
• Please refer to the product listing for full details of products affected.
• Please note, there is also a Product Recall which affects the same products. See our Useful Links section to view ICN 2949.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Baxter advise customers may continue to use Welch Allyn Non-Automated Blood Pressure Gauges if the device is tested by their Medical Engineering Department, and recalibrated if necessary.
• For further information please click on the link hillrom.com/content/dam/hillrom-aem/us/en/sap-documents/LIT/80025/80025959LITPDF.pdf to view the Instructions for Use, (IFU) for these devices.
• Complete and return the Customer Reply From, page 3 of the Field Safety Notice and return to Baxter: uk_shs_fca@baxter.com

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.