Field Safety Notice Baxter Healthcare Welch Allyn Non-Automated Blood Pressure Gauges Packaging Issue (ICN 2949)

NHSSC: 14

Alert:

• Baxter Healthcare has issued a Field Safety Notice recalling unopened Blood Pressure Cuff Kits, still in their original packaging, following discovery of a latex containing rubber band used in the packaging. These re-usable blood pressure cuffs are labelled “not made with natural rubber.”
• Baxter advise if the person opening the packaging has an allergy to latex, they may experience symptoms that include a rash, itching, swelling, sneezing etc. Certain people with a latex allergy are at a remote risk for a critical, systemic reaction such as anaphylaxis.
• Additionally, exposure of a patient or caregiver to residual latex protein, transferred to the cuff from the rubber band, cannot be ruled out.
• Baxter advise they have not received any reports of injury associated with this issue.

Products Affected:

• Eight of the products affected are available from NHS Supply Chains eDirect route.
• Please refer to the product listing for full details of the affected products.
• Please note, there is also a Product Alert which affects the same products. See our Useful Links section to view ICN 2948.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete and return the Customer Reply Form, page 3 of the Field Safety Notice, and return to: uk_shs_fca@baxter.com whether you have affected devices or not.
• On receipt of the reply form, where unopened affected devices are found, Baxter will contact you and organise replacements.
• Please note this recall does not apply to reusable blood pressure cuffs that have been opened and are currently in use.

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.