Urgent Field Safety Corrective Action – LIFECATH PICC+MST DOUBLE 4.5FG B10
15th January 2025
Urgent Field Safety Corrective Action – LIFECATH PICC+MST DOUBLE 4.5FG B10
FSCA – Identifier: 2501/51058/00
Type of Action: RECALL
| Product Code: | Batch/Lot: | NHSSC Code: |
| 001294345 | 101024GT | FSU373 |
Description of Problem
Due to an injection moulding fault a partial quantity of the grey hub of the affected batches might be damaged and the hub may not withstand the mechanical stresses which could be applied to it. Furthermore, a leakage at the hub might have a subsequential effect.
Field Safety Corrective Action Instructions:
Advice on action to be taken by Medical Staff
- Identify and quarantine any remaining stock of the affected product codes and batch/lot numbers.
- If you do not have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Email Back Form, complete the form, and send it to the email address: technical-uk@vygon.com.
- If you have stock from the affected batch number, stated above, mark the according checkbox on the enclosed FSCA Email Back Form, provide the additional information requested, and send the completed form to the email address: technical-uk@vygon.com.
- On receipt of the completed FSCA Email Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and replacements.
- Please complete these actions by 03-02-2025.
Instruction for Distributors of affected batch numbers
If you are a distributor, please provide this Field Safety Corrective Action (FSCA) to all your customers who have received stock of the affected product codes and batch numbers, as stated above. Please send your customers the following documents:
- A copy of this Field Safety Corrective Action
- A copy of the FSCA Fax Back Form
The FSCA Fax Back Form should be completed by your customer and returned to you.
As a distributor you are required to confirm to Vygon (UK) Ltd that you have completed the instructed activity for all of your customers affected by this Field Safety Corrective Action. Please forward all completed FSCA Fax Back Forms to the following fax number: 01793 748899 or email:
technical@vygon.co.uk
Please also identify and quarantine any remaining stock of the affected batch number in your warehouse, complete the FSCA Fax Back Form and forward it to the following fax number: 01793 748899 or email: technical@vygon.co.uk
On receipt of the completed FSCA Fax Back Form, a Vygon (UK) Ltd. representative will contact you to arrange return of the affected stock and credit.
Please complete these actions by 20-09-2023.
Vygon (UK) Ltd
Vygon (UK) Ltd has informed all customers, employees of Vygon (UK) Ltd and distributors of this Field Safety Corrective Action
Transmission of this Field Safety Corrective Action
This notice needs to be passed on to all recipients/users of this product within your organisation, in particular, the following:
- All departments/wards
- MHRA Liaison Officer
- Risk Managers
- Medical Device Safety Officer
- Medical Directors
- Nursing Directors
- Procurement
Please consider end users, clinicians, risk managers, supply chain/distribution centers etc. in the circulation of this FSCA.
Please maintain awareness of this FSCA and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Contact Person
Kate O’Connell
Technical Support Department
Vygon (UK) Ltd
The Pierre Simonet Building
V Park, Gateway North
Latham Road
Swindon
Wiltshire
SN25 4DL
Telephone: 01793 748800
Email: technical@vygon.co.uk
Vygon (UK) Ltd apologise for any inconvenience this FSCA may cause. This FSCA has been communicated to the MHRA.
Kate O’Connell
Technical Support Manager
E-mail: technical@vygon.co.uk