Field Safety Notice Sarstedt Blood Culture Adapter (ICN 2778)

NHSSC: 82

Alert:

• Sarstedt has issued a Field Safety Notice regarding specific batches of blood culture adapters 14.1209 and 14.1207.
• Due to a production-related error, leaks due to an incorrectly fitted membrane may occur in very rare cases of the affected batches.
• It is then possible that air will be drawn when filling a blood culture bottle and can lead to false negative results.

Products Affected:

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

• Please note only the batches quoted in the Field Safety Notice are affected.
• NHS Supply Chain has checked our warehouses, all future issues will be of different, unaffected Lot numbers.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Before using the blood culture adapters from the above-mentioned batch, please ensure that the membrane disc fits snugly and does not bulge (see Figure one, page two of the notice).
• If you identify any blood culture adapters with misaligned membranes, please separate these and contact the supplier directly to arrange replacement.
• Complete and return the Customer Response form, page four of the notice, to: gb@sarstedt.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.