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