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.