Intersurgical Neonatal Resuscitation Systems (ICN 1193)

Important Customer Notice Recall

Ref: 2021/1193 ICN Number: 1193

MHRA: 2021/001/012/291/002.

NHSSC:  71

Alert:       

  • Intersurgical has issued a product recall against specific lot numbers of five neonatal resuscitation systems following discovery of incorrect or missing connection interfaces.
  • This may prevent connection of the system to the equipment you use.

Products Affected:  

  • Three of the five products listed are available from NHS Supply Chain.
NPC Description Supplier Code/MPC Affected Lot Numbers
FDD2680 10mm Flextube neonatal resuscitation system with variable peep 6430000 32054366, 32055044, 32056212, 32013769
FDE643 10mm Flextube neonatal resuscitation system B/Variable peep double swivel elbow 6431000 32009718, 32011698, 32012922, 32013285, 32055153, 32055853, 32056243, 32056356
FDC1377 10mm Flextube neonatal resuscitation system, variable peep, double swivel elbow and universal connectors 1.2m 6433000 32055115, 32056099, 32009831, 32011359, 32012926
NA Neonatal resuscitation system, variable peep,2M 6431009 32055678
NA 10mm Flextube resuscitation system low volume chamber 1.3 M 6431014 32056289

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice (see our Downloads ▼ section) and share this document with all users of the affected products.
  • Immediately quarantine and destroy all affected product codes and lot numbers listed above and do not use these devices.
  • Contact Intersurgical by completing the response form found on page 3 of the Field Safety Notice confirming quantities disposed, or that you have none of the affected lot numbers, and email to priority@intersurgical.co.uk.
  • Contact your NHS Supply Chain Customer Service Advisor with full details to enable us to monitor and manage credit on your behalf.
  • The supplier has confirmed that all future orders are of unaffected lot numbers and have sufficient stock.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor

Downloads ▼

  • 1193 Intersurgical Field Safety Notice

    A PDF document of the Field Safety Notice for ICN 1193.