Product Recall Greiner Bio-One VACUETTE® HOLDEX® Single-Use Holder PP Single-Packed Sterile KFK111 (ICN 2724)

• Greiner Bio-one has advised NHS Supply Chain of four further affected Lot numbers to the ICN issued 31 October 2024.

• Please note this product code is currently suspended and unavailable to order.
• There are potential indirect alternatives available to order:
  • KFK037 – Becton Dickinson – white for 13mm and 16mm diameter tubes single use
  • KFK970 – GBUK Healthcare – Blood Collection Support Product Holder Sampling
  • KFK232 (Luer Adaptor) and KFK322 (Standard Tuber Holder) – Greiner Bio-one – need to be ordered together.
• Please see the attached product listing for more information available alternatives.
• Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.
• Cease use and quarantine the affected Lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including product code, Lot number and quantity.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This confirmation must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

MHRA TBC

NHSSC: 65

Alert:

• Greiner Bio-One has notified us about a Lot specific product recall regarding their single packed, sterile VACUETTE® HOLDEX® Single-Use Holder.
• Greiner Bio-One advise this recall is due to a very small number of reports where the rubber sheath had not fully retracted when a blood sample tube has been removed, resulting in blood continuing to flow from the open needle.
• Greiner Bio-One are issuing this recall for safety reasons and regulatory compliance.

Products Affected:

• The affected product has been supplied by NHS Supply Chain stocked route after 1 July 2024:

• Please note only the two Lot numbers quoted above are affected.
• We have quarantined the affected Lot numbers held in our depots and future orders will be fulfilled with unaffected product.

Next Steps:

• Cease use and quarantine the affected Lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including product code, Lot number and quantity.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This confirmation must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

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.