Field Safety Notice FVCA – 2023-001 Avanos Ballard Oral Care Swab Incorrect Expiry Dates (ICN 2062)

MHRA TBC

NHS Supply Chain Reference: 96 / 96B

Update

• Avanos has updated its Field Safety Advisory Notice FCA-2023-001, issuing a second notice dated 15 June 2023, to include an additional lot number.

•  Please check for this lot number and follow the instructions as below.

Alert:

• Avanos has issued an urgent precautionary Field Safety Advisory Notice affecting certain lots of the Avanos* Ballard* Oral Care products that were distributed with incorrect expiration dates on the label.
• The labelled expiration dates of the impacted products were printed with a 10-year expiration date however, the products have an established shelf life of 5 years.
• The intended use of these products is to apply a mouth moisturizer as well as wiping the lips, mouth, teeth, and soft tissue of patients who require oral hygiene assistance.
• There are currently no expired products among the impacted lots, therefore there is no immediate patient risk and all products listed in Appendix 1 are safe to use on patients. However, the impacted products should not be used past their actual expiration dates.
• The hazardous situation with an expired product is the potential for the component to break or detach leading to the potential for a minor choking hazard.

Products Affected:

• Two of the affected product codes are available from NHS Supply Chain.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.

Next Steps:

• Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
• Ensure all users are aware of the correct expiration dates of the impacted products and are safely used on patients prior to expiry.
• There is no need to return any impacted product to Avanos.

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