Field Safety Notice Getinge EWD Disinfectant Quality Hold on Aperlan Yoke Agent A and Yoke Agent B (ICN 2199)

• Getinge Limited has issued an updated Field Safety Notice dated 4 August 2023 to provide customers with the affected lot numbers for the two EWD Disinfectants Aperlan agent A and Agent B.
  • Aperlan Poka-Yoke agent A affected Lot numbers: 1596531, 1597269 and 1597674.
  • Aperlan Poka-Yoke agent B affected Lot numbers: 1596068, 1597809 and 1598089.
• Read and follow the instructions in the updated Field Safety Notice and share them with all users.
• Read the Safety Data Sheet (SDS) previously provided for Aperlan Poka-Yoke agent A and Aperlan Poka-Yoke agent B and follow the instruction regarding handling and protective equipment.
• Check the Lot-number on the canister.
• If any of the canisters at your facility correspond with the Lot number on the Customer Response Form (Appendix 1), please discard the canister according to your local regulations in terms of dangerous goods.
• Do not use any canisters from the affected lot numbers. The efficacy of the product and the safety of the operator cannot be guaranteed.
• Please adhere to local operational COSSH procedures and the Safety Data Sheets (SDS) in case of leakage.
• Complete the Customer Response Form, page 6 of the Field Safety Notice and return this form to: uki@getinge.com
• Contact your local NHS Supply Chain Customer Service Advisor with details of all products disposed of to enable us to manage your credit as appropriate.

• The supplier Getinge Limited has issued an updated Field Safety Notice dated 17 July 2023 to provide customers with details of how to inspect EWD Disinfectants Aperlan agent A and Aperlan agent B containers for deviation. It also explains the action that needs to be performed to prevent issues with these products which could lead to a hazardous situation if not supervised carefully.
• Read and follow the instructions in the Field Safety Notice, including reading the Safety Data Sheets (SDS), in regards the use of protective equipment during handling of this product. See our Downloads ▼ section.
• This Field Safety Notice needs to be distributed to those individuals who need to be aware within your organisation, or to any organisation where the potentially affected products have been transferred.
• Please maintain awareness of this notice and resulting action for the use period of the product to ensure effectiveness of the corrective action.
• Do not use any canisters with deviating caps. The efficacy of the product and the safety of the operator cannot be guaranteed.
• Please adhere to local operational COSSH procedures and the Safety Data Sheets (SDS) in case of leakage.
• Complete and sign the enclosed Customer Response Form (Appendix 1), page 6 of the Field Safety Notice and return this form to: uki@getinge.com.
• If you detect containers with deviations, complete Appendix 2, page 7 with full details of all defective cannisters that need to be discarded due to defective caps and email to: uki@getinge.com.
• Please also contact your local NHS Supply Chain Customer Service Advisor with these details.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

Alert:

• Getinge Limited has detected a quality issue with their Aperlan Poka Yoke Agent A and Agent B used for ED flow and Poka Yoke machines.
• There is a potential risk of leakage from the disinfectant cannisters.
• In the interest of safety, both products have been placed on hold and are unavailable to order.

Products Affected:

• These products, currently unavailable, are available on NHS Supply Chains eDirect Service:

Next Steps:

• Getinge has emailed all affected customers requesting they undertake a stock take and where available use alternative EWD machines in trusts to prolong product availability. This will help them understand stock levels and give an indication of when they could reach critical levels to help with national planning.
• Please note there are no alternatives currently available. NHS Supply Chain is working with the Supplier and National Bodies to review options.
• A full global stock check is being undertaken. An update will be issued as soon as possible on completion.

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

Please be aware that in the event of a Field Safety Notice or 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.