Spinning and Non-spinning Spiros male luer leaks (ICN 1228)

Important Customer Notice Field Safety Notice

Ref: 2021/1228 ICN Number: 1228

MHRA: 2021/003/012/701/025

NHSSC: 89

Alert:     

  • ICU Medical has issued a Field Safety Notice following discovery of the potential for leaks to occur with the Spiro male luer in certain lots due to a moulding defect.
  • The leak occurs when the Spiro is not activated and prior to connecting to a patient’s intravenous administration set.
  • The issue pertains to both spinning and non-spinning Spiros and was discovered through internal testing.
  • Fluid leakage prior to connection to an intravenous administration set may potentially cause delay of infusion or exposure to hazardous/ allergenic medications. ICU Medical has not received reports of leaks or patient harm related to this issue.

Products Affected:  

  • There is one NHS Supply Chain product code affected:
NPC MPC Description Lot Number Unit of issue
FSB1240 CH3235 (44H323501) Administration Set for Plum A Plus pump 5125276 Box of 50
  • Please note only the one lot number 5125276 is affected.
  • Current stocks in NHS Supply Chain warehouses have been checked and supplies of different lot numbers are available.
  • Refer to the Field Safety Notice (see our Downloads ▼ section) for further information on the affected products.

Next Steps:            

  • Follow the instruction in the Field Safety Notice including cease use of the affected lot number.
  • Contact your local NHS Supply Chain Customer Service Advisor with details of affected products of lot number 5125276 in your possession, please be clear if these are eaches or boxes of 50.
  • Your Customer Service Advisor will advise you regarding disposal and manage the appropriate credit on your behalf.

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

 

 

 

Downloads ▼

  • 1228 ICU Medical Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1228.
  • 1228 ICU Medical Letter of Destruction

    A PDF of the Letter of Destruction for ICN 1228.