Field Safety Notice Medical Device Alert Fannin Ltd Air-Q Laryngeal Masks Multiple Products (ICN 2224)

Alert:

• We have received a Medical Device Product Correction letter issued in relation to a product notification involving the Air-Q3G and Air-Q3 SPG ILA laryngeal masks with gastric access.
• The supplier Fannin Ltd. has been informed that the labelling in the instructions for use (IFU) and the printed text on the devices indicate an orogastric (OG) tube size discrepancy.
• Please see our Downloads ▼ section to also refer to the correct recommended maximum OG Tube/Catheter sizes for each Air-Q3 model listed in the SunMed’s Product Correction Notice.
• The products have been evaluated by the manufacturer as safe to use and not considered high risk.

Products Affected:

• 39 affected product codes are available from NHS Supply Chain.
• Please see our Downloads ▼ section to refer to the product listing for details of the affected product codes.
• Please note only the batch numbers listed on page three of SunMed’s notice are affected.

Next Steps:                     

• Read and follow the full instructions in the Medical Device Correction Notice and share them with all users of the affected products.
• Complete the Product Notification Response Form and return it at your earliest convenience to ford@fannin.eu. stating that you have read and understood the product correction letter.
• Please note this is not a Field Safety Notice – the manufacturer advises any products that you might still have in stock do not need to be returned and can be used, taking into consideration the correct information listed in the attached letter.
• Corrective measures to rectify the issue have been put in place and current supplies are not affected.

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