Medtronic Covidien DAR™ Airway Products (ICN 1259)

Important Customer Notice Field Safety Notice

Ref: 20201/1259 ICN Number: 1259

MHRA: TBC
Medtronic: FA975
NHS Supply Chain Ref: 7

Alert:

  • Medtronic has issued a Field Safety Notice relating to specific lots of Covidien DAR™ airway products.
  • Medtronic was notified by their supplier of sterilization services, Steril Milano, of potential deviations from validated parameters for ethylene oxide sterilisation.
  • The full impact of the deviations is still being investigated, and Medtronic is analysing data to assess whether sterilization has been achieved despite the deviations.

Products Affected:

  • There are 32 NHS Supply Chain products affected.
  • strong>See our Downloads ▼ section to refer to the Field Safety Notice and Product Listing for more information on the affected products.
  • Please note only lots listed in the Field Safety Notice are affected.
    Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Immediately quarantine and discontinue use of item codes with associated lot numbers listed in Attachment A.
  • Unaffected stock remains available for most of the affected codes and therefore customers should continue to order as normal.
  • Where stock availability may be constrained over the next few weeks on some products thresholds will be applied to orders and customers will be directed to review the details of suitable alternatives.
  • An update to this ICN will be issued in the next few days with further details including a more comprehensive list of alternatives as they are added.
  • Medtronic have recovered manufacturing of this product range and we envisage that normal supply will be re-established within the next 3 to 4 weeks
  • Medtronic will communicate with affected customers regarding the finding of their investigation once complete and will provide direction on what customers should do with the devices quarantined because of this Field Safety Notice.
  • If you have any questions regarding this communication, please contact your Medtronic representative via 01923 212213.

This ICN will continue to be updated accordingly once more information has been received. If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1259 Medtronic Field Safety Notice

    A pdf of the Field Safety Notice for ICN 1259
  • 1259 Medtronic Product Listing with Alternatives

    A MS Excel file detailing the affected product codes for ICN 1259.

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