Urgent Field Safety Corrective Action – LIFECATH PICC+MST DOUBLE 4.5FG B10

Published 15th January 2025

Notice - Recall

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

  1. Identify and quarantine any remaining stock of the affected product codes and batch/lot
    numbers.
  2. 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.
  3. 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.
  4. 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.
  5. Please complete these actions by 03-02-2025.