Product Recall Intersurgical Neonatal Nasal Cannula with Curved Prongs and Tube 2.1m (ICN 1897)
Important Customer Notice Update
Ref: 2022/1897
ICN Number: 1897
MHRA TBC
NHS Supply Chain Reference: 68
Update:
- Following further consultation with the MHRA, Intersurgical has issued a revised Field Safety Notice (FSN) to formally recall the affected devices listed in FSN 385183.
- Please note this Product Recall Notice supersedes the previous Field Safety Notice 385183.
Next Steps:
- Follow the instructions in the revised FSN, including ceasing use of affected Lot numbers.
- Contact your local NHS Supply Chain Customer Service Advisor with full details of the products in your possession, including Lot numbers. Your advisor will confirm the details and give you a unique CMS reference number.
- Upon receipt of confirmation in writing (quoting your CMS reference number), dispose of the affected Lot number products in accordance with your local regulations.
- A full credit will be raised.
- Target date for all actions to be completed is Friday 7 January 2023.
If you have any further questions regarding this update, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.
MHRA TBC
NHS Supply Chain Reference: 68
Alert:
- Further to our ICN published 28 November 2022, please find updated information and actions.
- NHS Supply Chain has received a Field Safety Notice from Intersurgical for specific Lots of Neonatal Nasal Cannula with Curved Prongs and Tube 2.1m after reports related to disconnection of the tube from the nasal prong section.
- If the oxygen tubing, which is connected to the nasal prong part of the device, becomes detached, oxygen will not be delivered to the patient.
- There is a risk of oxygen desaturation/hypoxaemia, which could cause life-threatening incidents.
Products Affected:
- The affected product is available from NHS Supply Chain as:
| NPC | Product Description | Supplier Code / MPC |
|
FDC038 |
Neonatal Nasal Cannula with Curved Prongs and Tube 2.1m |
1164000 |
- Please refer to the Field Safety Notice for details on the affected Lots.
- We have quarantined all affected Lots held in our network and future orders will be supplied with unaffected stock.
Next Steps:
- Read and share the Field Safety Notice with all users.
- Customers are to review the actions contained within the Field Safety Notice.
- Should you choose not to use affected product, please contact your local NHS Supply Chain Customer Service Advisor. Your advisor will arrange a return for full credit using reason code 7 Supplier Recall. All goods to be returned no later than Friday 7 January 2023.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
MHRA TBC
NHSSC : 68
Alert:
- NHS Supply Chain has received a Field Safety Notice from Intersurgical for specific Lots of Neonatal Nasal Cannula with Curved Prongs and Tube 2.1m after reports related to disconnection of the tube from the nasal prong section.
- If the oxygen tubing, which is connected to the nasal prong part of the device, becomes detached, oxygen will not be delivered to the patient.
- This ICN is to make customers aware of this notice whilst we investigate the issue further from the supplier.
Products Affected:
- The affected product is available from NHS Supply Chain as:
| NPC | Product Description | Supplier Code / MPC |
| FDC038 | Neonatal Nasal Cannula with Curved Prongs and Tube 2.1m | 1164000 |
- Please refer to the Field Safety Notice for details on the affected Lots.
Next Steps:
- Read and share the Field Safety Notice with all users.
- We will update this ICN with actions we have taken and any further advice moving forward.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.
Downloads ▼
-
1897 Intersurgical Field Safety Notice 6 December 2022
A PDF file to show the Field Safety Notice for ICN 1897.
-
1897 Intersurgical Instructions for Use 28 November 2022
A PDF file to show the Intersurgical Instructions for Use for ICN 1897.
-
1897 Intersurgical Customer Response Form 6 December 2022
A PDF file to show the customer response form for ICN 1897.