Product Recall Radiometer Limited Arterial Blood Sampler FWC169 (ICN 1616)

Important Customer Notice Recall

Ref: 2022/1616 ICN Number: 1616

Alert:

  • 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.

Products Affected:

  • 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.

Next Steps:

  • 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.

Downloads ▼

  • 1616 Radiometer Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1616.
  • 1616 Radiometer Product Listing

    An Excel file detailing the affected product codes for ICN 1616.
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