Field Safety Notice Linc Medical Systems Ltd Silicone Foley Catheters Multiple Products (ICN 1621)

Important Customer Notice Field Safety Notice

Ref: 2022/1621 ICN Number: 1621

Alert: 

  • Linc Medical Systems Ltd has issued a Field Safety Notice to inform customers that the Instructions for Use (IFU) document for all silicone foley catheters provided by the supplier has been updated.
  • The following are the changes to the instruction for use (IFU) that are of note:

o    – Before use, check the catheter and balloon by inflating. Fully deflate the balloon after functional inspection.

Products Affected:

  • There are four affected products that are supplied via NHS Supply Chain eDirect route:
NPC Product Description Supplier Code/ MPC
FSR180 Catheter Suprapubic 12FG 08451205H
FSR181 Catheter Suprapubic 14FG 08451405H
FSR182 Catheter Suprapubic 16FG 08451610H
FSR179 Catheter Suprapubic 8FG 08470803H

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Complete the Acknowledgment Form, found on page 3 of the Field Safety Notice, see our Downloads ▼ section and return to lincadmin@linc-medical.co.uk.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Downloads ▼

  • 1621 Linc Medical Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1621.