Field Safety Notice GBUK Enteral-ISOSAF Home 1ml Low Dose ENFit Single Patient Use Syringe FTR2105 (ICN 3505)

NHSSC: 69

Alert:

• GBUK has issued a Field Safety Notice regarding specific Lots of its Enteral-ISOSAF home 1ml low dose ENFit single patient use syringe.
• GBUK’s internal review following a customer complaint identified that devices from the affected batches contain a single use symbol on the syringe barrel in error.
• This issue is limited to the product print only and does not affect the overall design, materials, or performance of the device.
• Additionally, the only error on the product print is the incorrect inclusion of the single use symbol (as per image 1 in the Field Safety Notice), all other markings are correct and within specifications, including the syringe graduations.
• Despite the presence of the single use symbol there is in fact no impact to reprocessing of the device. These batches remain suitable to reuse as per issued guidance for single patient use.

Products Affected:

• One product is affected.
• The affected product is stocked by NHS Supply Chain:

• Please note only the batch numbers quoted in the Field Safety Notice are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• The affected syringes remain suitable for their intended use as a reusable single patient use device.
• The single use symbol is present in error and does not affect the safety, performance or intended use of the device.
• No action is required by users or customers in relation to the devices already supplied.

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