Medtronic Covidien DAR™ Airway Products Withdrawal FA975 Phase ll (ICN 1259)

Important Customer Notice Update

Ref: 20201/1259 ICN Number: 1259

MHRA 2021/004/029/291/001

NHSSC: 7A

Update

  • Medtronic has issued a market withdrawal notice, FA975 Phase ll dated June 2021, for the specific production lots of the Covidien DAR™ airway products.
  • Medtronic has concluded its investigation of potential deviations in the ethylene oxide sterilization processes performed by Steril Milano.
  • Medtronic analysis concluded there was no quality issues for production lots where data was available. Where data was not available for investigation, Medtronic have concluded that those specific production lots will be voluntarily recalled.
  • As a UK Distributor of this range, HC21 Healthcare has issued a supporting notice to facilitate next steps.

Next Steps

  • Follow the instruction in HC21’s withdrawal notice dated 9 June 2021.
  • Ensure all affected lot numbers are quarantined.
  • Please note only lots listed in the product listings are affected.
  • There are 36 affected products, as detailed in the product listing, supplied by NHS Supply Chain’s eDirect service or from stock held in our warehouses.

For eDirect products:

  • Complete the verification form with details of the quantity of products and lot numbers.
  • To facilitate collection HC21 require a contact name, fax and or email address and the full address of where the goods are held.
  • Forward the verification form either by Fax to +35318855558 or email compliance@hc21.ie.

For stocked products:

  • Please contact your local NHS Supply Chain Customer Service Advisor with full details, including any part packs, to arrange a return for full credit (reason code 7 Supplier Recall). All goods to be returned no later than Friday 11 July 2021.
  • If you have any questions regarding this Field Safety Notice please contact HC21 on tel: 021487 5055 and one of their product specialists will be happy to provide you with additional information.
  • An additional product / lot number has been identified as issued by NHS Supply Chain:
NPC Product Description Supplier Code/MPC Route Lot Number
FSQ460 Catheter closed suction system trach. 12fg 444sp01312 eDirect 20G1531FAX
  • Our records indicate you may have received this product / lot number combination; please check and if found, follow the instructions in the Field Safety Notice.
  • See our Downloads ▼ section to view the revised product listing for further information on the affected product code.
  • NHS Supply Chain apologies for omitting to highlight this device in our original communication.

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.
  • 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

    An Excel file detailing the affected product codes for ICN 1259.
    Login to view the downloads
  • 1259 HC21 Verification Form

    A PDF of the Verification Form for ICN 1259.
  • 1259 HC21 Withdrawal Notice

    A PDF of the Withdrawal Notice for ICN 1259.