Product Recall Radiometer Limited Arterial Blood Sampler FWC169 (ICN 1616)
Important Customer Notice Resolved
- FWC169 has now been delisted from our online catalogue.
- Potential alternative products are now available to order through our online catalogue.
- See our Downloads section to refer to the product listing and the potential alternative product codes.
- Please refer to the ICN update below dated 13 April 2022 for full details on this product recall.
- A further potential alternative product has been identified.
- See our Downloads section to view the updated product listing for the potential alternative product codes.
- Radiometer Limited has issued a Field Safety Notice withdrawing all in-date lot numbers of the PICO50 Arterial Blood Sampler.
- The issue relates to the sterile barrier system for the product.
- The described error may potentially result in bacterial bloodstream infection.
- The affected product is available from NHS Supply Chain as:
|NPC||Product Description||Supplier Code/ MPC||Affected Lot|
|FWC169||Blood Gas Syringe PICO50 (pack 100)||956-552||All|
- Please note the affected product has been suspended and all outstanding orders cancelled.
- Potential indirect alternative products are available, please see our Downloads ▼ section to view the product listing for the potential alternative product codes.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Stop using the affected product with immediate effect.
- Identify and quarantine all affected stock.
- Contact your NHS Supply Chain Customer Service Advisor with full details of full, and any part packs.
- Following verification, you will be requested to arrange disposal of the affected devices in line with your local regulations. On confirmation of disposal by email, full credit will be raised on your behalf.
- Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.