Cook Medical Zenith Alpha Abdominal Endovascular Graft (ICN 1112)

Important Customer Notice Recall

Ref: 2020/1112 ICN Number: 1112

MHRA 2020/008/010/487/007
NHSSC: 38

Alert:

  • Cook Medical has identified that specific lots of the Zenith Alpha Abdominal Endovascular Graft (ZIMB main body) may contain excess glue within the handle of the delivery system.
  • This may result in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU.
  • Potential adverse events that may occur if an affected product is used include a prolonged procedure and/or open surgical repair.

Products Affected:

  • There are 76 affected products available via NHS Supply Chain’s eDirect route.
  • See our Downloads ▼ section to refer to the Field Safety Notice and product listing for further information on the affected product codes.
  • Please note only the lot numbers listed in the Field Safety Notice are affected.
  • Devices already implanted are not affect by this recall.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Quarantine any affected product/ lots.
  • Customers are to complete the Customer Reply Form and email it to European.FieldAction@CookMedical.com.
  • If you have any of the affected products please contact your NHS Customer Service Advisor with full details to enable us to monitor a return direct to the supplier and manage your credit.

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

Downloads ▼

  • 1112 Cook Medical Product Listing

    An Excel file detailing the affected product codes for ICN 1112.
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  • 1112 Cook Medical Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1112.