Field Safety Notice Baxter Healthcare Limited Welch Allyn Power Cords FFF3068 (ICN 2572)

Alert:

• Baxter has issued a Field Safety Correction Notice for the power cords used with the Welch Allyn ProBP 3400 Digital Blood Pressure Welch Allyn Spot Vision Screener following reports of an issue relating to the cord construction not meeting the insulation rating for international standards.
• Non-compliant cords are more susceptible to physical damage incurred over time due to thinner insulation than on compliant cords.
• Baxter advise if a user is exposed to a visibly damaged power cord the injury incurred would most likely be minor to moderate, such as discomfort, tingling or a minor burn; more serious health consequences may occur in rare situations and higher risk populations.
• Baxter confirm they have not received any reports of patient injury associated with this potential safety issue.

Products Affected:

• One of the products affected is available from NHS Supply Chain:

• Baxter confirm they are currently working to obtain compliant cords. An update will be issued with details of availability and how to obtain compliant replacement cords as soon as possible.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Inspect the power cord for damage. If fraying or other damage is observed discard the power cord immediately.
• Healthcare providers may continue to use the affected power cords following inspection and no visible damage is observed on the cord.
• Healthcare providers should regularly inspect the cords for fraying or damage.
• Complete the Customer Reply Form, page 4 of the notice and email to: 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.